Danh mục Thuốc bị thu hồi FDA 2018-2021

 Thu hồi thuốc là cách hiệu quả nhất để bảo vệ công chúng khỏi một sản phẩm bị lỗi hoặc có khả năng gây hại. Thu hồi là hành động tự nguyện của một công ty vào bất kỳ lúc nào để loại bỏ một sản phẩm thuốc bị lỗi khỏi thị trường.

Danh sách dưới đây bao gồm các đợt thu hồi tự nguyện đã được thông báo công khai.

Date Brand-Names Product-Description Recall-Reason-Description Company-Name Terminated-Recall

06/18/2019 Premier Pharmacy Labs All Products Intended to be Sterile Lack of Sterility Assurance Premier Pharmacy Labs Inc Terminated

06/18/2019 RXQ Compounding LLC All sterile human and animal products within expiry. Lack of Sterility Process Assurance RXQ Compounding LLC

06/20/2019 Infusion Options Inc. All sterile products within expiry Lack of Sterility Assurance Infusion Options Inc.

06/26/2019 Macleods Losartan Potassium USP tablets and Losartan Potassium/Hydrochlorothiazide combination tablets Presence of NMBA impurity Macleods Pharmaceutical  Limited Terminated

07/02/2019 Fresenius Kabi, Novaplus Fluorouracil Injection Potential for glass particulate Fresenius Kabi USA, LLC

07/03/2019 Perrigo Ophthalmic ointments Potential for nonsterility Altaire Pharmaceuticals, Inc.

06/28/2019 PharMEDium 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe The electronic customer ordering system stated it is sulfite-free, but the product contains sulfite. PharMEDium Services, LLC Terminated

07/03/2019 Walgreens Eye drops and ophthalmic ointments Potential for nonsterility Altaire Pharmaceuticals, Inc.

07/05/2019 Equate and Support Harmony Over-the-Counter (OTC)  drug products Potential for nonsterility Altaire Pharmaceuticals, Inc.

07/10/2019 CVS Health Multiple Ophthalmic Products Due to lack of assurance of sterility Altaire Pharmaceuticals, Inc

07/16/2019 OCuSOFT Prescription (RX) and Over-the-Counter (OTC) Ophthalmic products Due to lack of sterility assurance Altaire Pharmaceuticals, Inc.,

07/15/2019 Altaire Pharmaceuticals, Inc. OTC and Rx Ophthalmic Products Due to lack of sterility assurance Altaire Pharmaceuticals Inc.

07/16/2019 Natural Ophthalmics, TRP/Target Up & Up Over-The-Counter Ophthalmic Products Due to lack of sterility assurance Altaire Pharmaceuticals, Inc.

07/16/2019 Accutome, Focus Laboratories, Grandall Distributing Co. Inc. , Prestige Over-The-Counter Ophthalmic Products Due to lack of sterility assurance Altaire Pharmaceuticals Inc.

07/23/2019 Cadista Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/ 0.02mg Due to out of specification (OOS) dissolution results at the 3-month stability time point Jubilant Cadista Pharmaceuticals Inc. Terminated

07/24/2019 Herbal Doctor Remedies Drug products All products have been marketed without FDA approval and were manufactured outside of the controls required by current Good Manufacturing Practices (cGMP) Herbal Doctor Remedies

07/15/2019 Equate and Support Harmony Over-the-Counter (OTC)  drug products Potential for nonsterility Altaire Pharmaceuticals, Inc.

08/08/2019 TAT Balm, Naturally HL 4% Lidocaine topical cream & liquid gel products Microbiological Contamination and Superpotency Ridge Properties LLC DBA Pain Relief Naturally

08/15/2019 RELPAX RELPAX® (eletriptan hydrobromide) 40 mg tablets Microbiological Contamination Pfizer Inc

08/22/2019 Dechra Veterinary Products Veterinary ophthalmic drug products Due to concerns of QA controls in the manufacturing facility Altaire Pharmaceuticals, Inc.

08/30/2019 AmEx Pharmacy Bevacizumab 1.25mg/0.05mL 31G Injectable and Bevacizumab 2.5mg/0.1ml Normject TB Injectable Potential for non-sterility Pacifico National, Inc. dba AmEx Pharmacy

09/06/2019 Hospira Inc. Bacteriostatic Water for Injection Potential Lack of Sterility Assurance Hospira Inc.

09/09/2019 Major Pharmaceuticals Milk of Magnesia Oral Suspension 2400 mg/30 ml Microbial Contamination Plastikon Healthcare

09/12/2019 KRS Global Biotechnology Human Sterile Drug Products Lack of Sterility Assurance KRS Global Biotechnology

09/12/2019 Darmerica LLC Quinacrine Dihydrochloride, bulk API powder Label mix-up Darmerica LLC Terminated

09/05/2019 Natpara Parathyroid Hormone for Injection Potential presence of rubber particulate Takeda Pharmaceutical Company Limited Terminated

09/16/2019 Macho MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT Undeclared Tadalafil Fitoterapia USA Inc. Terminated

09/19/2019 Torrent Pharma Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP Due to the Detection of N-Methylnitrosobutyric acid (NMBA) Torrent Pharmaceuticals Limited

09/23/2019 Sandoz Inc. Ranitidine Hydrochloride Capsules Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) Sandoz Inc.

09/25/2019 Apotex Corp. Ranitidine Tablets 75mg and 150mg Contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) Apotex Corp.

10/10/2019 Innoveix Pharmaceuticals, Inc. Injectable Human Chorionic Gonadotropin (HCG) and injectable Sermorelin w/GHRP2 Potential lack of sterility assurance Innoveix Pharmaceuticals, Inc.

11/05/2019 Viatrexx Sterile injectable products Lack of sterility assurance Viatrexx Bio Incorporated Terminated

10/22/2019 Green Lumber Dietary supplements for male sexual enhancement Contains Tadalafil GL Holdings

10/23/2019 Dr. Reddy’s, Kroger, Walgreens, and others Ranitidine Tablets & Capsules Contains N-Nitrosodimethylamine (NDMA) Dr. Reddy’s Laboratories Ltd.

10/23/2019 Sanofi Zantac 150, Zantac 150 Cool Mint, Zantac 75 (OTC Products) May Contain N-Nitrosodimethylamine (NDMA) Sanofi

10/23/2019 Perrigo Company plc Ranitidine (all pack sizes) Presence of N-Nitrosodimethylamine (NDMA) Perrigo Company plc

10/25/2019 Novitium Pharma Ranitidine Hydrochloride Capsules 150 mg and 300 mg May contain N-Nitrosodimethylamine (NDMA) Novitium Pharma

10/26/2019 Mylan Pharmaceuticals Inc. Alprazolam Tablets, USP C-IV 0.5 mg Potential presence of foreign substance Mylan Pharmaceuticals Inc. Terminated

10/25/2019 Lannett Company, Inc. Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Due to above levels of N-Nitrosodimethylamine (NDMA) Lannett Company, Inc.

10/30/2019 ICU Medical, Inc. Lactated Ringer's Injection, USP and 0.9% Sodium Chloride Injection, USP Due to the presence of particulate matter ICU Medical, Inc. Terminated

11/01/2019 Fagron LETS GEL KIT Convenience Packs Potentially contain microbial contamination in the non-sterile Suturagel Fagron Inc.

11/06/2019 Aurobindo & DG Health Ranitidine NDMA (Nitrosodimethylamine) Aurobindo Pharma USA, Inc.

11/08/2019 AHP Ranitidine Liquid Unit Dose Cups NDMA (Nitrosodimethylamine) impurity American Health Packaging

11/08/2019 Up2 Up2 THERE IS NO OTHER All Natural Libido for Men & Women Dietary Supplement Product is tainted with sildenafil Med Man Distribution

11/22/2019 Amneal Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL Due to potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA Amneal Pharmaceuticals, LLC

11/13/2019 Silver Bullet Male Enhancement Capsules Due to unapproved active ingredient (sildenafil) Nature’s Rx

11/15/2019 GSMS Incorporated Ranitidine HCl 150mg and 300mg Capsules Potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA GSMS, Inc.

11/19/2019 PrecisionDose Ranitidine Oral Solution, USP 150 mg/10 mL Potential presence of N-Nitrosodimethylamine (NDMA) above levels established by the FDA Precision Dose Inc.

12/17/2019 No Brand name Listed on Package Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, Panther Platinum 30000 Presence of Undeclared Tadalafil Motto International Corp Terminated

12/17/2019 Glenmark Ranitidine Tablets 150mg and 300mg NDMA (Nitrosodimethylamine) impurity Glenmark Pharmaceuticals, Inc.

12/18/2019 Lannett Levetiracetam Oral Solution Bacillus subtilis Lannett Company, Inc. Terminated

12/31/2019 Aurobindo Pharma USA, Inc. Mirtazapine Tablets 7.5 mg Due to a label error on declared strength-bottles labeled as Mirtazapine 7.5 mg Aurobindo Pharma USA, Inc.

01/07/2020 ani Ranitidine Tablets 150mg and 300mg NDMA (Nitrosodimethylamine) impurity Appco Pharma LLC Terminated

01/08/2020 Mylan Nizatidine Capsules 150mg and 300mg NDMA (Nitrosodimethylamine) impurity Mylan N.V. Terminated

01/08/2020 Northwind Ranitidine Tablets 150mg and 300mg NDMA (Nitrosodimethylamine) impurity Denton Pharma, Inc. dba Northwind Pharmaceuticals

01/10/2020 Taro Pharmaceuticals Lamotrigine Tablets, USP 100mg Cross contamination with another drug substance, Enalapril Maleate Taro Pharmaceuticals U.S.A., Inc.

01/16/2020 AXIA Pharmaceutical Sterile Drug Products Lack of Assurance of Sterility FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutcal

01/31/2020 Efficient Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX liquid due to Microbial Contamination Efficient Laboratories, Inc.

02/21/2020 Taro Pharmaceuticals U.S.A., Inc. Phenytoin Oral Suspension USP, 125 mg/5 mL Possible underdosing or overdosing Taro Pharmaceuticals U.S.A., Inc.

02/27/2020 American Health Packaging Ranitidine Tablets, USP 150mg NDMA (Nitrosodimethylamine) impurity American Health Packaging

03/05/2020 West-Ward Ketorolac Tromethamine Injection, USP 30mg/mL, 1 mL Vial Potential Presence of Small Particulates Hikma Pharmaceuticals USA Inc. Terminated

03/26/2020 Dr. Reddy’s Laboratories Ltd. Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules Ampules breaking & shattering Dr. Reddy’s Laboratories Ltd.

04/15/2020 Gemini Laboratories Nizatidine Oral Solution 15 mg/mL NDMA (Nitrosodimethylamine) impurity Amneal Pharmaceuticals, LLC Terminated

04/16/2020 Heritage Tetracycline HCl Capsules, 250mg and 500mg Due to low out of specification dissolution results Avet Pharmaceuticals Labs Inc.

04/20/2020 Fresenius Kabi Ketorolac Tromethamine Injection, USP, 30 mg/mL, and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL Presence of Particulate Matter Fresenius Kabi USA, LLC

04/20/2020 B. Braun Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container Out-of-Specification Results for High Molecular Weight Polymers Braun Medical Inc Terminated

04/27/2020 QuVa R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe presence of particulate matter QuVa Pharma, Inc. Terminated

05/11/2020 MasterPharm, LLC Finasteride Plus 1.25mg, capsules Contains undeclared minoxidil MasterPharm, LLC

07/28/2020 KORE ORGANIC Watermelon CBD oil tincture Contains lead Summitt Labs

05/20/2020 Biota Biosciences Cannabidiol (CBD) Complex, Curcumin Complex, Cannabidiol + Curcumin Unapproved new drug Biota Biosciences, LLC

05/22/2020 Acella 30-mg, 60-mg and 90-mg NP Thyroid® Super potency Acella Pharmaceuticals, LLC

06/05/2020 Apotex Corp Metformin Hydrochloride Extended-Release Tablets, USP 500mg Due to detection of N-Nitrosodimethylamine (NDMA) Apotex Corp

06/01/2020 Amneal Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg Due to detection of N-Nitrosodimethylamine (NDMA) Amneal Pharmaceuticals LLC

06/05/2020 Actavis Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg Due to detection of N-Nitrosodimethylamine (NDMA) Teva Pharmaceuticals USA Inc.

06/05/2020 Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500mg Due to detection of N-Nitrosodimethylamine (NDMA) Marksans Pharma Limited, India

06/18/2020 Robitussin Cough and cold products Incorrect dosing cups GSK Consumer Healthcare

06/27/2020 Saniderm Advanced Hand Sanitizer May contain methanol (wood alcohol) Saniderm Products

06/29/2020 Saniderm Advanced Hand Sanitizer, 70% alcohol content Potential presence of methanol (wood alcohol) UVT, INC.

07/02/2020 Mystic Shield Mystic Shield Protection Topical Solution Undeclared methanol Transliquid Technologies LLC

07/06/2020 All Clean Hand sanitizer Potential presence of methanol (wood alcohol). ITECH 361

07/06/2020 Granules Metformin Hydrochloride Extended-Release Tablets USP, 750 mg N-Nitrosodimethylamine (NDMA) Granules Pharmaceuticals, Inc.

07/07/2020 Mylan Daptomycin for Injection Presence of particulate matter Mylan Institutional LLC

07/13/2020 Blumen Hand Sanitizer Undeclared Methanol 4e Brands North America

07/14/2020 bio aaa Hand Sanitizer Potential Undeclared Methanol Contamination AAA Cosmetica, S.A. de C.V.

07/14/2020 Bersih Hand Sanitizer Gel Potential Methanol Contamination Soluciones Cosmeticas

07/17/2020 Multiple brand names Hemp Oil Tinctures Excess lead in product InHE Manufacturing, LLC

07/20/2020 Optimus Hand Sanitizer Potential Methanol Contamination LIQ-E S.A. de C.V.

07/22/2020 Fresenius Kabi Dexmedetomidine Hydrochloride Injection, 200 mcg/50 mL Cross contamination with lidocaine Fresenius Kabi USA

07/24/2020 Born Basic, Scent Theory and more Hand Sanitizer Undeclared methanol Real Clean Distribuciones SA de CV

07/24/2020 Shine & Clean Hand Sanitizer Gel Potential presence of methanol (wood alcohol) Maquiladora Miniara, S.A. de C.V.

07/27/2020 Assured, Blumen, Modesa Hand Sanitizer Undeclared Methanol 4e Brands North America

07/27/2020 Resource Recover & Trading, LLC Hand Sanitizer Undeclared Methanol subpotency ethyl alcohol Resource Recovery & Trading, LLC

07/28/2020 Herbacil Hand Sanitizer Undeclared Methanol Broncolin S.A. de C.V

08/18/2020 Nuuxsan, Modesa, more Hand Sanitizer Undeclared Methanol ALBEK de Mexico S.A. de C.V.

08/01/2020 Jaloma Hand Sanitizer Undeclared Methanol Laboratorios Jaloma S.A. de C.V.

08/04/2020 Command Brands Hand Sanitizer Methanol Contamination Roque Plast S.A. de C.V.

08/05/2020 Ferring, Amring, CSL Behring DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL Superpotency Ferring Pharmaceuticals US

08/07/2020 Gelbac T Antibacterial Handgel Methanol Contamination Incredible Products Sa de Cv

08/09/2020 Bersih Hand Sanitizer Gel Potential Methanol Contamination Soluciones Cosmeticas

08/10/2020 (Becton, Dickinson and Company) ChloraPrep™ 3 mL applicator Potential fungal contamination - Aspergillus penicillioides (Becton, Dickinson and Company)

08/15/2020 SkinGuard24 All Day Hand Sanitizer Contains Methanol SG24 LLC

08/18/2020 Maison Terre Goldenseal Root Powder Due to microbial contamination Maison Terre

08/18/2020 SCA Pharma Heparin Sodium Compounded products Incorrect preservative (benzyl alcohol) SCA Pharmaceuticals

08/18/2020 Yacana Yacana Hand Sanitizer, 70% Alcohol Potential Presence of Methanol (Wood Alcohol) and sub-potent ethanol Grupo Yacana México S.A.S de C.V.

08/20/2020 FLORANCE MORRIS Antiseptic Hand Sanitizer, 70% Alcohol Potential Methanol Contamination Grupo Asimex de Mexico SA de CV

08/20/2020 Bayshore Pharmaceuticals, LLC Metformin Hydrochloride Extended-Release Tablets USP, 500 mg & 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity Bayshore Pharmaceuticals, LLC

08/25/2020 V-Klean, Medical Minded, Protz Hand Sanitizer Potential presence of methanol (wood alcohol) and subpotent ethanol levels Asiaticon SA de CV

08/26/2020 Zanilast+ Hand sanitizer Product contains 1-propanol. Nanomateriales, SA de CV

08/28/2020 Harmonic Nature Hand sanitizer Product contains 1 propanol HARMONIC NATURE S. DE R.L. Mi

08/31/2020 Always Be Clean, Just Hand Sanitizer Products labeled to contain methanol Open Book Extracts

08/31/2020 Mylan Tranexamic Acid and Amiodarone HCl injections Vials potentially packaged in incorrect cartons Mylan N.V.

09/01/2020 Red-E Red-E male enhancement tablet Product contains undeclared sildenafil The Protein Shoppe, LLC

09/03/2020 bio aaa Hand Sanitizer Possible presence of methanol AJR Trading LLC

09/03/2020 RLC Labs Nature-Throid® and WP Thyroid® Product may be sub potent RLC Labs, Inc

09/03/2020 Leafree Hand sanitizer Product is labeled as edible alcohol. CorgioMed LLC

09/10/2020 M M Hand Sanitizer Alcohol Antiseptic 80% Contains Methanol and may be Sub-Potent for Ethanol Medek, LLC

09/17/2020 NP Thyroid 15 & NP Thyroid120 Thyroid Tablets Sub Potency Acella Pharmaceuticals, LLC

09/23/2020 Riomet ER Metformin Hydrochloride for Extended-Release Oral Suspension Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity Sun Pharmaceutical Industries Terminated

09/30/2020 Cleaner Cleaner Hand Sanitizer Potential Presence of Methanol (Wood Alcohol) Estado de México, México, DMM VISSION, S.A. de C.V

10/02/2020 Smart Care Hand sanitizer packaged in 0.84 oz. pouches Product is packaged in containers resembling a food and drink pouch Ashtel Studios

10/05/2020 Time-Cap Labs Inc. Metformin Hydrochloride for Extended-Release Tablets, USP 500 mg and 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity Marksans Pharma Limited

10/28/2020 Paroex Paroex Chlorhexidine Gluconate Oral Rinse, 4 oz and 16 oz Potential contamination with Burkholderia lata Sunstar Americas, Inc.

11/02/2020 Nostrum Laboratories Metformin HCl Extended Release Tablets, USP 750 mg NDMA exceeds acceptable daily intake limit Nostrum Laboratories

11/03/2020 Nostrum Laboratories Metformin HCl Extended Release Tablets, USP 500 mg NDMA exceeds acceptable daily intake limit Nostrum Laboratories

11/09/2020 Lohxa Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free May be contaminated with Burkholderia lata Lohxa, LLC

11/19/2020 Fresenius Kabi USA Dexmedetomidine HCL in 0.9% Sodium Chloride Injection Cross Contamination with Lidocaine Fresenius Kabi USA

11/23/2020 CORE, Immune Boost CORE essential nutrients and Immune Boost Sublingual Vitamin D3 Unapproved new drug Fusion Health and Vitality LLC

12/01/2020 WishGarden Herbal Remedies Happy Ducts Compress Product may be contaminated with Cronobacter sakazakii. WishGarden Herbs

12/02/2020 MPM Medical Regenecare HA Topical Anesthetic Hydrogel Burkholderia cepecia contamination. MPM Medical, LLC

12/04/2020 WishGarden Herbal Remedies Cord Care and Goldenseal Powder Product may be contaminated with Cronobacter sakazakii WishGarden Herbs, Inc.

12/09/2020 AvKare Sildenafil 100 mg tablets and Trazodone 100mg tablets Due to product mix-up AvKare

12/09/2020 Torrent Pharmaceuticals Limited Anagrelide Capsule USP 1mg Due to dissolution test failure Torrent Pharmaceuticals Limited

12/23/2020 IMC Wash-Free Hand Sanitizer Undeclared Methanol Shane Erickson, Inc. DBA Innovative Marketing Consultants

12/28/2020 Paroex Paroex Chlorhexidine Gluconate Oral Rinse, 4 oz and 16 oz Potential contamination with Burkholderia lata Sunstar Americas, Inc.

12/31/2020 GUM Paroex Paroex Chlorhexidine Gluconate Oral Rinse, 15 mL unit dose cups Potential contamination with Burkholderia lata Precision Dose Inc.

01/04/2021 Soho Fresh 70% Rubbing Alcohol Contaminated with Methanol Essaar Inc.

01/04/2021 Nostrum Laboratories Metformin HCl Extended Release Tablets, USP 750 mg NDMA exceeds acceptable daily intake limit Nostrum Laboratories

01/08/2021 Fresenius Kabi Ketorolac Tromethamine Injection, USP, 30 mg/mL Presence of particulate matter Fresenius Kabi USA

01/25/2021 Nostrum Laboratories, Inc. Metformin HCl Extended Release Tablets, USP 750 mg Due to levels of nitrosamine impurities above the ADI limit of 96 ng/day Nostrum Laboratories, Inc.

01/27/2021 Meitheal Pharmaceuticals, Inc. Cisatracurium Besylate  Injection, USP 10mg per 5mL Mislabeling Meitheal Pharmaceuticals, Inc.

02/03/2021 Apotex Corp. Enoxaparin Sodium Injection, USP Packaging error resulting in incorrect dosage listed Apotex Corp

07/13/2021 Innoveix Pharmaceuticals, Inc. Injectable Semorelin / Ipamorelin 3mg and injectable AOD-9604 3mg Potential lack of sterility assurance Innoveix Pharmaceuticals, Inc.

07/14/2021 Neutrogena, Aveeno Sunscreen Testing identified low levels of benzene Johnson & Johnson

07/19/2021 CHANTIX Smoking cessation treatment N-Nitroso Varenicline content above ADI level Pfizer

08/10/2021 SterRx, LLC Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL Due to waterborne microbial contamination SterRx, LLC

08/11/2021 Max Health Hydro Pineapple Burn undeclared sibutramine Ebay Seller-John Nguyen

08/16/2021 CHANTIX Smoking cessation treatment N-Nitroso Varenicline content above acceptable daily intake level Pfizer

09/03/2021 Teligent Lidocaine HCl Topical Solution 4% Super potency Teligent Pharma, Inc.

09/07/2021 Hospira Aminosyn II, 15%, An Amino Acid Injection, Sulfite Presence of visible particulate matter ICU Medical, Inc.

09/08/2021 Azurity Firvanq Product kit may contain incorrect diluent. Azurity Pharmaceuticals, Inc.

09/13/2021 Ruzurgi® Ruzurgi® (amifampridine) 10 mg tablets Exceeds Specification for Total Yeast and Mold Counts Jacobus Pharmaceutical Company Inc.

09/16/2021 CHANTIX Varenicline tablets N-nitroso-varenicline above acceptable daily intake level Pfizer

09/21/2021 IntegraDose Compounding Services, LLC Cefazolin Lack of sterility assurance. IntegraDose Compounding Services, LLC

09/26/2021 Lilly Glucagon Emergency Kit Loss of potency Eli Lilly and Company

09/30/2021 Coppertone Coppertone aerosol sunscreen spray products Presence of benzene Coppertone, owned by Beiersdorf

10/01/2021 Lotrimin® AF and Tinactin® Over the Counter (OTC) antifungal spray products Presence of benzene Bayer U.S. LLC

10/12/2021 Teligent Pharma, Inc. Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) Super Potent Teligent Pharma, Inc.

10/14/2021 Lupin Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mg API batches above the specification limit for the impurity, N-nitrosoirbesartan Lupin Pharmaceuticals, Inc.

10/19/2021 Bryant Ranch Prepack Methocarbamol 500mg Bottles labeled as Methocarbamol 500mg tablets were found to contain Methocarbamol 750mg tablets. Bryant Ranch Prepack

10/20/2021 CUBICIN Daptomycin for injection 500mg Product contains particulate matter identified as glass Merck

10/27/2021 artnaturals Scent Free Hand Sanitizer Due to Presence of Impurities artnaturals

02/16/2021 Adam’s Secret Adam’s Secret Extra Strength 1500 and Adam’s Secret Extra Strength 3000 capsules Product contains undeclared sildenafil and/or tadalafil Adamssecret.co

03/09/2021 BRP Pharmaceuticals Spironolactone TB 25MG and 50MG Incorrect strength displayed on the label Bryant Ranch Prepack

03/11/2021 Sagent Phenylephrine Hydrochloride Injection Lack of sterility assurance Sagent Pharmaceuticals, Inc.

03/17/2021 Heal the World Hand Sanitizer Because they resemble water bottles; risk of ingestion PNHC, LLC d/b/a Heal the World

03/24/2021 Alembic Telmisartan Tablets, USP, 20 mg Incorrect Product Strength on Label Alembic Pharmaceuticals, Inc.

03/24/2021 Durisan Antimicrobial Hand Sanitizer Due to microbial contamination Sanit Technologies LLC d/b/a Durisan

03/25/2021 Zydus Pharmaceuticals Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials Due to Crystalization Zydus Pharmaceuticals Inc.

03/24/2021 ChloraPrep; BD ChloraPrep ChloraPrep 3 mL Applicator Potential Aspergillus penicillioides contamination (Becton, Dickinson and Company)

03/25/2021 Imperial Dietary Supplement for Male Enhancement Undeclared Sildenafil & Tadalafil S&B Shopper LLC

03/26/2021 PremierZen Dietary Supplement for male sexual enhancement Undeclared Sildenafil and Tadalafil Namoo Enterprise LLC

03/29/2021 Thumbs Up 7 Dietary Supplement for male sexual enhancement Undeclared Sildenafil and Tadalafil Antoto-K

03/30/2021 Thumbs Up 7 Blue 69K Dietary Supplement for male sexual enhancement Undeclared Sildenafil and Tadalafil Bit & Bet LLC

03/31/2021 Thumbs Up 7, Shogun, Krazy Night Dietary Supplement for male sexual enhancement Undeclared Sildenafil, Tadalafil, Vardenafil Ummzy LLC

03/31/2021 Thumbs Up 7, Shogun-X, 69MODE Dietary Supplement for male sexual enhancement Undeclared Sildenafil, Tadalafil, Vardenafil Nuri Trading LLC

03/31/2021 Apotex Corp. Guanfacine Extended-Release Tablets 2mg Trace amounts of Quetiapine Fumarate Apotex Corp.

04/02/2021 A-S Medication Solutions, LLC Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles contained in Health Essentials Kits distributed by Humana Products contain an incomplete prescription drug label A-S Medication Solutions, LLC

04/05/2021 IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 Dietary Supplement for male sexual enhancement Undeclared Sildenafil and/or Tadalafil QMART

04/06/2021 PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 Dietary Supplement for male sexual enhancement Undeclared Tadalafil Yolo Studio

04/09/2021 NS NY Distributor Inc Premium Orgazen 7000 and Ginseng Power 5000 capsules Undeclared Sildenafil and/or Tadalafil NS NY Distributor Inc

04/16/2021 Durisan Hand sanitizer Product is contaminated with Burkholderia contaminans Sanit Technologies LLC d/b/a Durisan

04/20/2021 ChloraPrep ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator Defective applicator Becton, Dickinson and Company

04/28/2021 Ulta Beauty Collection & SS Scented Hand Sanitizer Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde Scentsational Soaps & Candles, Inc.

04/30/2021 Acella NP Thyroid (Thyroid Tablets, USP) Sub potency Acella Pharmaceuticals, LLC

05/04/2021 Hospira, Inc. 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and 1% Lidocaine HCl Injection, USP 30 mL Due to mislabeling Hospira, Inc.

05/04/2021 Hospira, Inc. Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial Due to visible particulate Hospira, Inc.

05/10/2021 Levemir, Tresiba, Fiasp, Novolog and Xultophy Product Samples Due to improper storage temperature conditions Novo Nordisk

05/11/2021 Poseidon Male Sexual Enhancement Dietary Supplement Undeclared Tadalafil and Sildenafil Yamtun7

05/12/2021 DIBAR Labs, ProtectoRx Hand Sanitizer Presence of methanol Dibar Nutricional S. de R.L. de C.V.

05/13/2021 Medically Minded Hand Sanitizer Presence of methanol Global Sanitizers

05/13/2021 Goose Creek, COCO TKO Hand Sanitizer Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde Scentsational Soaps & Candles, Inc.

05/17/2021 Durisan Hand sanitizer Product is contaminated with Burkholderia contaminans Sanit Technologies LLC d/b/a Durisan

05/19/2021 DIBAR Labs, ProtectoRx Hand Sanitizer Presence of methanol Dibar Nutricional S. de R.L. de C.V.

05/25/2021 Medically Minded Hand Sanitizer Presence of methanol Global Sanitizers

05/28/2021 Imperia Elita Imperia Elita Vitaccino Coffee Undeclared Sibutramine and Fluoxetine Dash Xclusive

06/11/2021 Viona Pharmaceuticals Inc. Metformin Hydrochloride Extended-Release Tablets Contains Nitrosodimethylamine (NDMA) impurities Viona Pharmaceuticals Inc.

06/22/2021 Prairie Wolf Distillery Hand sanitizer packaged in 16.9 fluid ounce and 20 fluid ounce containers that resemble water bottles Packaged in containers resembling water bottles Prairie Wolf Spirits, Inc.

06/22/2021 Durisan Hand sanitizer and hand sanitizing wipes Microbial contamination Sanit Technologies LLC d/b/a Durisan

07/01/2021 Teva Topotecan Injection 4 mg/4 mL (1 mg/mL) Presence of particulate matter Teva Pharmaceuticals

07/01/2021 Limar Hand sanitizer Packaged in bottles that resemble drink containers Ardil Commercial

02/08/2018 Alvogen Clindamycin Injection USP Due to Lack of Sterility Assurance Alvogen Terminated

02/08/2018 Bristol-Myers Squibb Eliquis (apixaban) 5 mg Tablets Potential Labeling Issue Bristol-Myers Squibb

02/07/2018 Ultra-Sten, D-Zine Marketed as a dietary supplement Unapproved drugs Hardcore Formulations

02/07/2018 PharMEDium Potassium Phosphate and Succinylcholine Chloride Intravia Bags Due to Lack of Sterility Assurance PharMEDium Services Terminated

02/08/2018 Super Panther 7K Dietary Supplement Unapproved new drug Ultra Shop Supplement Terminated

02/08/2018 ICU Medical, Inc. 0.9% Sodium Chloride Injection, USP 1000 mL Due to the Presence of Particulate Matter ICU Medical, Inc. Terminated

02/08/2018 Andropharm Sten Z and M1 Alphas capsules Contain derivatives of anabolic steroids Andropharm Terminated

02/07/2018 Apace Packaging LLC Cyclobenzaprine HCl Tablet and Amantadine HCl Capsule Cyclobenzaprine HCL may contain Amantadine HCL Capsules Apace Packaging LLC Terminated

02/08/2018 Man of Steel Man of Steel 1 and Man of Steel 2 Due to Presence of Undeclared Sildenafil Man of Steel Terminated

02/08/2018 LaBri's Body Health Dietary Supplement Due to presence of Sibutramine EZ Weight Loss TX Terminated

02/08/2018 Cantrell Drug Company All unexpired sterile drug syringes and IV bags Due to Lack of Sterility Assurance Cantrell Drug Company

02/08/2018 Rugby Diocto Liquid and Diocto Syrup Potential contamination with Burkholderia cepacia Rugby® Laboratories

02/08/2018 Amneal Pharmaceuticals LLC Lorazepam Oral Concentrate, USP 2mg/mL Due to Misprinted Dosing Droppers Amneal Pharmaceuticals LLC

02/06/2018 Atlantic Pharmacy and Compounding All compounded injectable prescription medications Lack of Sterility Assurance Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding Terminated

02/08/2018 Piyanping Anti-Itch Lotion Due to Incorrect Active Ingredient Lucky Mart Inc. Terminated

02/08/2018 Doctor Manzanilla Allergy, cough medicine Burkholderia Cepacia Mid Valley Pharmaceutical Terminated

02/06/2018 Leader, Major, Rugby Liquid drug products Possible contamination Cardinal Health Terminated

08/30/2017 Hospira, Inc. Vancomycin Hydrochloride for Injection Due to the Presence of Particulate Matter Hospira, Inc. Terminated

02/06/2018 Centurion Ninjacof and Ninjacof A Potential contamination with Burkholderia cepacia Centurion Labs Terminated

02/06/2018 International Laboratories, LLC Pravastatin Sodium Tablets Labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets International Laboratories, LLC Terminated

02/09/2018 Bella Pharma All lots of unexpired sterile drug products Lack of Sterility Bella Pharmaceuticals, Inc. Terminated

02/06/2018 HYDROmorphone, Levophed Hydromorphone HCl, Levophed Due to Lack of Sterility Assurance Hospira, Inc. Terminated

02/06/2018 PharMEDium Oxytocin Sub-Potency PharMEDium Services, LLC Terminated

02/08/2018 Genentech Activase® (alteplase) 100mg vials Due to Lack of Sterility Assurance Genentech Terminated

10/19/2017 A1 Dietary Supplement A1 Slim Unapproved new drug; tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine Kiriko, LLC

10/05/2017 Baxter INTRALIPID 20% IV Fat Emulsion, 100 mL Product exposed to subfreezing temperatures Baxter International Inc. Terminated

10/20/2017 SCA Pharmaceuticals LLC Injectable drugs Lack of Sterility Assurance SCA Pharmaceuticals LLC Terminated

10/19/2017 A1 Slim Dietary Supplement A1 Slim Unapproved new drug; tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine Kiriko, LLC Terminated

01/16/2018 Nexterone Amiodarone HCl Presence of Particulate Matter Baxter International Inc Terminated

12/29/2017 Greenstone LLC diphenoxylate hydrochloride and atropine sulfate tablets, USP Due to Possible Sub Potent and Super Potent Tablets Greenstone LLC, a wholly owned subsidiary of Pfizer Inc. Terminated

12/29/2017 Fresenius Kabi USA Midazolam Injection, USP prefilled syringe Mislabeled Fresenius Kabi USA Terminated

12/29/2017 Ridge Properties DBA Pain Relief Naturally Pain and itch relief products Manufacturing Concerns Ridge Properties DBA Pain Relief Naturally Terminated

12/29/2017 Sun Pharma Riomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mL Microbial Contamination (Scopulariopsis brevicaulis) Sun Pharmaceutical Industries Ltd Terminated

12/29/2017 AuroMedics Pharma LLC Pantoprazole Sodium for Injection 40 mg per vial Contains glass particles AuroMedics Pharma LLC Terminated

12/29/2017 Pharmacist Choice Alcohol Prep Pads Due to Lack of Sterility Assurance Simple Diagnostics Terminated

12/29/2017 AuroMedics Linezolid Injection White particulate matter that has been identified as mold AuroMedics Pharma Terminated

12/29/2017 Marmex Corp Male Enhancement Unapproved new drug Marmex Corp Terminated

01/11/2018 PharMEDium Services, LLC Compounded injectables Lack of Sterility PharMEDium Services, LLC Terminated

01/10/2018 AuroMedics Pharma LLC Ampicillin and Sulbactam for Injection USP Presence of Glass Particles in Vial AuroMedics Pharma LLC Terminated

01/25/2018 AuroMedics Levofloxacin in 5% Dextrose Injection 250mg/50mL Due to the Presence of Particulate Matter AuroMedics Pharma LLC Terminated

01/11/2018 PharMEDium Services LLC Various compounded drug products intended to be sterile Lack of Sterility PharMEDium Services LLC Terminated

01/16/2018 Nexterone Nexterone 150mg/100ml injection Due to the Presence of Particulate Matter Baxter International Inc. Terminated

01/10/2018 International Laboratories, LLC Clopidogrel Tablets USP, 75 mg Due to Mislabeling International Laboratories, LLC Terminated

01/24/2018 Basic Drugs Senna Laxative Due to Mislabeling Magno-Humphries Laboratories, Inc. Terminated

06/02/2018 Gericare Sterile Eye Irrigation Solution Potential microbial contamination which compromises sterility Kareway Products Inc. Terminated

01/29/2018 Limbrel Limbrel, Limbrel 250, Limbrel 500 Due to adverse event reports of elevated liver function tests or acute hypersensitivity pneumonitis Primus Pharmaceuticals, Inc. Terminated

02/15/2018 AVpak Acyclovir Tablet, USP, 400mg, 50ct Unit Dose Due to Product Mix-up Apace Packaging LLC Terminated

02/23/2018 Hospira, Novaplus Labetalol Hydrochloride Injection, USP Due to Potential Of Cracked Glass At The Rim Surface Of The Vials Hospira, Inc. Terminated

04/13/2020 Sagent Methylprednisolone Sodium Succinate for Injection, USP 40mg, 125mg, and 1g Due to High Out of Specification Impurity Results Sagent Pharmaceuticals Terminated

04/09/2020 Bayer Alka-Seltzer Plus Mislabeling-The ingredients on the front sticker may not match the actual product in the carton Bayer Terminated

03/22/2018 BD Vacutainer tubes Inaccurate lead test results BD

04/13/2020 Hospira, Inc. Hydromorphone HCL Injection, USP Due to The Potential for Empty or Cracked Glass Vials Hospira, Inc. Terminated

04/07/2020 PASTA DE LASSAR ANDROMACO Pasta De Lassar Andromaco Skin Protectant Due to Potential Contamination of high levels of yeast, mold, and bacteria MarcasUSA, LLC Terminated

04/07/2020 PASTA DE LASSAR ANDROMACO Pasta De Lassar Andromaco Skin Protectant Due to Potential Contamination of high levels of yeast, mold, and bacteria MarcasUSA, LLC Terminated

04/07/2020 AMA Wholesale Inc. Rhino 69 Extreme 50000 capsules Undeclared tadalafil AMA Wholesale Inc. Terminated

04/11/2018 Premier Pharmacy Labs Sterile Injectable Drug Products Due to a Potential Lack of Sterility Assurance Premier Pharmacy Labs Terminated

03/30/2020 7K and Poseidon 7K and Poseidon 4500 Dietary Supplements Undeclared Sildenafil and Tadalafil Shoreside Enterprises Terminated

05/14/2018 AuroMedics Pharma LLC Piperacillin and Tazobactam for injection, USP 3.375 g/vial Due to Presence of Glass Particulates AuroMedics Pharma LLC

05/14/2018 AuroMedics Pharma LLC Ampicillin and Sulbactam for Injection USP, 3 grams/ Single-Dose vial Visible Particulate Matter AuroMedics Pharma LLC

05/14/2018 Apotex Corporation Piperacillin and Tazobactam for Injection Ingredient Level Apotex Corporation

03/30/2020 MBI Distributing, Inc. Various Homeopathic Products Lack of Adequate Controls MBI Distributing, Inc. Terminated

03/30/2020 Ethanol Extraction/Lake Michigan Distilling Company, LLC 95% Ethyl Alcohol product Methanol Lake Michigan Distilling Company, LLC dba Ethanol Extraction Terminated

03/27/2020 X-Jow, Acne Shave Pain Gel, Moisturizer, Shave Cream Bacteria Shadow Holdings Terminated

06/21/2018 Gaia Ethnobotanical Kratom Products Salmonella Gaia Ethnobotanical, LLC

05/29/2018 Taytulla Birth control capsules Due to Out of Sequence Capsules Allergan

06/04/2018 Hospira Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use cartridge Syringe System Potential of Foreign Material Hospira Inc. Terminated

05/31/2018 Apotex Fluticasone Propionate Nasal Spray Small Glass Particles Apotex Corp.

03/31/2020 HeartMate 3 Left Ventricular Assist Device potential safety risk to patients, such as low blood flow or clotting. Abbott Terminated

07/16/2018 "Major

Pharmaceuticals" Valsartan tablets, 80mg USP and 160 mg USP may contain the probable carcinogen Nnitrosodimethylamine (NDMA) Major Pharmaceuticals

03/24/2020 Fagron Sterile Services Neostigmine Methylsulfate 5 mL Syringes Mislabeling Fagron Sterile Services Terminated

08/14/2018 Kratom Powder Capsule Kratom Powder Capsule Potential to be contaminated with Salmonella Blissful Remedies

06/27/2018 Hospira Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial Adverse event reports indicative of infusion reactions Hospira Inc.

07/18/2018 Prinston Pharmaceutical Inc. dba Solco Healthcare LLC Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) Prinston Pharmaceutical Inc. dba Solco Healthcare LLC

03/24/2020 Actavis Valsartan and Valsartan Hydrochlorothiazide Tablets Impurity Teva Pharmaceuticals USA Terminated

07/20/2018 Dr. King’s, Dr. King’s Aquaflora Homeopathic liquids: Candida liquid, lymph detox liquid, baby teething liquid microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans. King Bio Inc.

07/31/2018 Auromedics Piperacillin and Tazobactam for injection, USP 3.375 g Due to Presence of Particulates Identified as Glass and Silicone Material AuroMedics Pharma

08/08/2018 CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination Product Quest Manufacturing (“Product Quest”)

03/20/2020 Westminster Pharmaceuticals, LLC Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg Due to Risk of Adulteration Westminster Pharmaceuticals, LLC Terminated

03/20/2020 Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity Camber Pharmaceuticals, Inc. Terminated

07/28/2018 Ranier's RX Laboratory Compounded drug products Due to Lack of Sterility Assurance Ranier's RX Laboratory

08/16/2018 Blissful Remedies Products Containing Kratom Due to High Microbial Loads Contamination World Organix, LLC

03/19/2020 Torrent Pharmaceuticals Limited Valsartan/Amlodipine/HCTZ; Valsartan/Amlodipine; and Valsartan tablets Impurity Torrent Pharmaceuticals Limited Terminated

03/20/2020 Torrent Valsartan/Amlodipine/HCTZ Tablets Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Torrent Pharmaceuticals Terminated

03/19/2020 Accord Hydrochlorothiazide Tablets USP 12.5 mg Due to Labeling Mix-up Accord Healthcare Inc. Terminated

08/28/2018 Dr. King’s Homeopathic products for human and animal use Microbial Contamination King Bio

03/19/2020 Neuroveen, Respitrol, Thyroveev, Compulsin Homeopathic Medicines Due to Possible Microbial Contamination HelloLife, Inc. Terminated

03/19/2020 SCA Pharmaceuticals Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag Due to Presence of Precipitate SCA Pharmaceuticals LLC (“SCA Pharma”) Terminated

09/06/2018 Beaumont Bio Med Homeopathic Homeopathic oral sprays Due to Possible Microbial Contamination Beaumont Bio Med, Inc.

03/19/2020 NeoRelief Muscle Due to Possible Microbial Contamination BioLyte Laboratories Terminated

08/24/2018 KB, DK, more Homeopathic products Microbial contamination King Bio

03/19/2020 Children’s Advil Ibuprofen Oral Suspension Dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL) Pfizer, Inc. Terminated

09/07/2018 Camber Pharmaceuticals Montelukast Sodium Tablets, USP 10mg Mislabeling Camber Pharmaceuticals, Inc

09/10/2018 Pharm D Solutions Compounded drugs Lack of Sterility Pharm D Solutions LLC

02/06/2018 Caverflo Natural Herbal Coffee Undeclared Active Pharmaceutical Ingredients and Undeclared Milk Caverflo.com Terminated

10/10/2018 ReGen Series All ReGen Series products Adverse reactions Liveyon, LLC

01/08/2019 Rhino Rhino 5K capsules Undeclared Sildenafil and Tadalafil Happy Together, Inc. Terminated

11/27/2018 Teva Pharmaceuticals Amlodipine/Valsartan Combination Tables and Amlopidine/Valsartan/Hydrochlorothiazide Combination Tablets Due to detection of NDEA (N-Nitrosodiethylamine) Impurity Teva Pharmaceuticals

11/12/2018 Oscor Temporary Bipolar Pacing Lead, Model TB Connector cap housing may slide and potentially expose the connection wire Oscor Inc.

12/17/2018 Envoachem Pharmaceuticals Dyural-40 and Dyural-80 Due to Latex Hazard Asclemed USA Inc dba Envoachem Pharmeceuticals

02/22/2019 Macleods Losartan Potassium/Hydrochlorothiazide Combination Tablets Due to detection of NDEA (N-Nitrosodiethylamine) Impurity Macleods Pharmaceuticals Limited

12/04/2018 Mylan Valsartan-containing products Due to the detection of NDEA (N-Nitrosodiethylamine) Impurity Mylan Pharmaceuticals

02/25/2019 Golean Detox Dietary Supplement for Weight Loss Mislabeling Golean Detox USA Terminated

01/18/2019 Prinston Pharmaceutical Inc. dba Solco Healthcare LLC Irbesartan and Irbesartan HCTZ Tablets Due to the detection of NDEA (N-Nitrosodiethylamine) Impurity Prinston Pharmaceutical Inc. dba Solco Healthcare LLC

02/08/2019 McDaniel Life-Line Indian Herb (topical) Unapproved drug. Marketed without an approved NDA/ANDA McDaniel Life-Line LLC Terminated

02/26/2019 ChemoLock and ChemoClave Vial Spikes Due to the Potential for Burr Particulate ICU Medical, Inc.

01/29/2019 CVS, Equate Oral ibuprofen Higher Concentration of Ibuprofen Tris Pharma, Inc.

03/01/2019 Apotex Corp. Drospirenone and Ethinyl Estradiol Tablets, USP Possibility of Missing/Incorrect Tablet Arrangement Apotex Corp.

03/01/2019 Aurobindo, Acetris Valsartan and Amlodipine and Valsartan tablets Due to the detection of NDEA (N-Nitrosodiethylamine) Impurity AurobindoPharma USA, Inc.

12/19/2018 Terrific Care LLC dba MedEx Supply Roche CoaguChek test strips Inaccurately reporting high INR test results Terrific Care, LLC. / Medex Supply Dist, Inc.

02/28/2019 Camber Pharmaceuticals, Inc. Losartan Tablets USP 25 mg, 50 mg, and 100 mg Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Camber Pharmaceuticals, Inc.

03/17/2020 ORTHO-NOVUM ORTHO-NOVUM 1/35 and 7/7/7 Due to Incorrect Veridate Dispenser Instructions Janssen Pharmaceuticals, Inc. Terminated

03/07/2019 Aurobindo Pharma USA, Inc. Valsartan Tablets USP Due to detection of N-Nitrosodiethylamine (NDEA) American Health Packaging Terminated

03/15/2019 Hospira Sodium bicarbonate injection USP Presence of Particulate Matter Hospira, Inc. Terminated

03/13/2019 Stokes Healthcare Pilocarpine opthalmic solution Due to a High Level of Preservative Stokes Healthcare, Inc.

01/22/2019 Torrent Pharmaceuticals Limited Losartan potassium tablets, USP; Losartan potassium and Hydrochlorothiazide tablets, USP Lack of Sterility Torrent Pharmaceuticals Limited

03/17/2020 Sprayology Homeopathic Aqueous-Based Medicines Possible microbial contamination Eight and Company LLC, dba Sprayology Terminated

03/11/2020 Family Wellness, CVS, Equate Infants’ Ibuprofen Due to Potential Higher Concentrations of Ibuprofen Tris Pharma Terminated

03/06/2019 Life-Line tm Additive for human drinking water Contaminated with Pseudomonas aeruginosa McDaniel Life-Line LLC

10/18/2018 Zero Xtreme Dietary Supplement for Weight Loss Due to Presence of Undeclared Sibutramine Fat Burners Zone

12/31/2018 Aurobindo Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP, Valsartan Tablets USP Due to detection of NDEA (N-Nitrosodiethylamine) Impurity Aurobindo Pharma USA, Inc.

10/22/2018 Promise Pharmacy Prednisolone and Gatifloxacin Ophthalmic Solution Due to Small Particulate Floating in the Solution Promise Pharmacy

01/03/2019 Torrent Pharmaceuticals Limited Losartan potassium tablets, USP Due to the detection of trace amounts of N-nitrosodiethylamine (NDEA) Torrent Pharmaceuticals Limited

03/19/2019 Legacy Losartan Potassium USP Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Legacy Pharmaceutical Packaging

03/18/2019 Mylan Levoleucovorin Injection, 250 mg/25 mL Presence of particulate matter Mylan Institutional LLC Terminated

03/25/2019 Leopard Dietary Supplement Undeclared Sildenafil USA LESS

03/28/2019 Legacy Losartan Potassium USP Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Legacy Pharmaceutical Packaging

03/17/2020 Aurobindo Pharma Limited Irbesartan Drug Due to detection of NDEA (N-Nitrosodiethylamine) Impurity Aurobindo Pharma Limited Terminated

01/08/2019 Sun Pharma Vecuronium Bromide for Injection Potential Foreign Material Sun Pharmaceutical Industries, Inc Terminated

01/05/2019 Lupin Pharmaceuticals, Inc. Ceftriaxone for Injection, USP Foreign Material Lupin Pharmaceuticals, Inc. Terminated

11/07/2018 Puriton Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle Due to Non-Sterile Production Conditions Kadesh Inc.

03/10/2020 Lubrisine Eye Drops Sterility Concerns and Undeclared Colloidal Silver Results RNA LLC Terminated

02/04/2019 Dr. Reddy’s Laboratories Ltd. Infusion Bags (Levetiracetram in 0.54% Sodium Chloride Injection) Mislabeling Dr. Reddy’s Laboratories Ltd.

11/21/2018 Fresenius Kabi Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex Fresenius Kabi USA

11/09/2018 Losartan Potassium Hydrochlorothiazide Due to detection of NDEA (N-Nitrosodiethylamine) Impurity Sandoz Inc

04/12/2019 Platinum 40000 Aphrodisiac capsules Unapproved Ingredient SD Imports

07/15/2019 Alvogen Fentanyl Transdermal System Due to Product Mislabeling Alvogen Terminated

04/18/2019 Torrent Pharmaceuticals Limited Losartan potassium tablets, USP; Losartan potassium and Hydrochlorothiazide tablets, USP Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Torrent Pharmaceuticals Limited

04/26/2019 GSMS Incorporated Losartan Potassium 25 mg and 100 mg Tablets USP Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Teva Pharmaceuticals USA, Inc Terminated

07/15/2019 Legacy Losartan Potassium USP Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Legacy Pharmaceutical Packaging

04/29/2019 AmEx Pharmacy Bevacizumab 1.25mg/0.05mL 31G Injectable Product Defect AmEx Pharmacy

03/01/2019 Torrent Pharma Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide Tablets USP Due to The Detection of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Torrent Pharmaceuticals Limited Terminated

12/20/2018 Torrent Pharmaceuticals Limited Losartan potassium tablets, USP Due to detection of NDEA (N-Nitrosodiethylamine) Impurity Torrent Pharmaceuticals Limited

04/30/2019 Sagent Pharmaceuticals Ketorolac Tromethamine Injection Lack of Sterility Sagent Pharmaceuticals

05/03/2019 Par Pharmaceutical Mycophenolate Mofetil for injection Foreign Material Par Pharmaceutical, Inc.

05/03/2019 Heritage Losartan Potassium Tablets USP Due to the detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) Vivimed

05/02/2019 Endo Pharmaceuticals Robaxin® (methocarbamol tablets, USP) 750mg Tablets Incorrect Daily Dosing Information on Label Endo Pharmaceuticals Terminated

05/03/2019 WP Westminster, more Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms Due to detection of NDEA (N-Nitrosodiethylamine) Impurity ScieGen Pharmaceuticals, Inc Terminated

03/15/2019 Legacy Losartan Potassium USP Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Legacy Pharmaceutical Packaging

03/20/2019 DG™/health NATURALS baby Cough Syrup + Mucus Potential to be contaminated with Bacillus cereus/ Bacillus circulans Kingston Pharma, LLC Terminated

05/12/2019 Promacta Promacta 12.5 mg oral suspension Due to Potential Peanut Contamination Novartis

05/23/2019 Pharm D Solutions Sterile Compounded Drug Products Lack of sterility assurance Pharm D Solutions, LLC Terminated

05/28/2019 Heritage Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL) Sterility Failure Heritage Pharmaceuticals Inc. Terminated

05/29/2019 Pecgen DMX, PECGEN DMX, 16 oz, liquid cough syrup Incorrect dosage on label NOVIS PR LLC Terminated

05/29/2019 Pecgen DMX, PECGEN DMX, 16 oz, liquid cough syrup Incorrect dosage on label NOVIS PR LLC

06/11/2019 GSMS Inc. Losartan potassium tablets Detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) Teva Pharmaceuticals USA, Inc. Terminated

02/08/2018 Apexxx Dietary Supplement Due to presence of Sildenafil Nuway Distributors

02/08/2018 Baxter intravenous (IV) solutions: 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container and 70% Dextrose Injection (2000 mL) USP Labeled as Eliquis5 mg was found to contain Eliquis 2.5 mg tablets Baxter International Inc.

02/06/2018 PharMEDium Norepinephrine Bitartrate added to Sodium Chloride Found to exhibit a slight discoloration in the admixture PharMEDium Services, LLC Terminated

02/06/2018 Advanced Pharma All unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma, Inc.’s Houston location Potential Inaccuracy of Latex Free Label Reference Avella Specialty Pharmacy Terminated

02/08/2018 Hospira, Inc. Vancomycin Hydrochloride for injection Due to the Presence of Particulate Matter Hospira, Inc. Terminated

02/08/2018 Synergy Rx Pharmacy Non-sterile drug products Lack of Quality Assurance Synergy Rx Pharmacy Terminated

02/08/2018 Edex Alprostadil for injection Potential Lack of Sterility Assurance Endo Pharmaceuticals Inc. Terminated

02/07/2018 Synergy Rx Pharmacy Human Chorionic Gonadotropin (HCG)for injection Due to Lack of Sterility Assurance Synergy Rx Pharmacy Terminated

02/08/2018 X-Gen Ibuprofen Lysine Injection, 20 mg/2 mL Some of the vials have been found to contain particulate matter Exela Pharma Sciences, LLC Terminated

02/07/2018 Isomeric Pharmacy Solutions Multiple compounded sterile products Due to Lack of Sterility Assurance Isomeric Pharmacy Solutions Terminated

02/08/2018 Hyland's Baby teething tablets and Nightime teething tablets Mislabeling Standard Homeopathic Company Terminated

02/09/2018 LaBri’s Body Health Dietary Supplement Mislabeling Envy Me Terminated

02/08/2018 Uproar, Cummor, Zrect, Monkey Business and others Dietary Supplement Undeclared Active Ingredients tadalafil, sildenafil and analogues Organic Herbal Supply, Inc. Terminated

02/08/2018 C.O. Truxton, Inc. Phenobarbital Tablets, USP, 15 mg Due to Labeling Error on Declared Strength C.O. Truxton, Inc. Terminated

02/08/2018 Hospira, Inc. 25% Dextrose Injection, USP (Infant) Due to the Presence of Particulate Matter Hospira, Inc.

02/06/2018 Truxton Incorporated Amitriptyline HCL Tablets, USP 50mg andPhenobarbital Tablets, USP 15mg, 30mg, 60mg, 100mg Label Mix-up Error C.O. Truxton, Inc. Terminated

02/06/2018 Advanced Pharma Potassium Phosphate and Succinylcholine Chloride Due to Lack of Sterility Assurance Advanced Pharma, Inc. d/b/a Avella of Houston Terminated

02/08/2018 Astrazeneca professional (physician) sample BRILINTA (ticagrelor) 90mg tablets Another medicine present Astrazeneca Terminated

02/06/2018 Teva Pharmaceuticals USA, Inc Paliperidone Extended-Release Tablets, 3mg Due to Dissolution Test Failure Teva Pharmaceuticals USA, Inc Terminated

02/06/2018 Lupin Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) Missing Expiry Lupin Pharmaceuticals Inc. Terminated

02/06/2018 Advanced Pharma Nitroglycerin products Due To Sub-Potency Advanced Pharma, Inc. d/b/a Avella of Houston Terminated

02/06/2018 Hospira 8.4% Sodium Bicarbonate Injection, USP, NeutTM (Sodium Bicarbonate 4% additive solution), QUELICINTM (Succinylcholine Chloride Injection, USP) and Potassium Phosphates Injection, USP Due to microbial growth Hospira Inc, A Pfizer Company Terminated

02/07/2018 Bristol-Myers Squibb Eliquis (apixaban) 5 mg Tablets Labeling Bristol-Myers Squibb

02/08/2018 The Green Herb AL-ER-G dietary supplement Presence of Ephedra Herb, an FDA banned ingredient MusclMasster LLC Terminated

02/08/2018 Tetracycline-ABC, Tetrastem, Diabecline and more topical products Manufacturing Practices Phillips Company Terminated

02/08/2018 Fagron Sterile Services Succinylcholine Chloride 20mg/mL Lack of Sterility Assurance Fagron Sterile Services Terminated

11/22/2021 Sagent Levetiracetam Injection Lack of sterility assurance Sagent Pharmaceuticals, Inc.

05/08/2020 ICU Medical Inc. Lactated Ringer’s Injection, USP Presence of particulates (iron oxide) ICU Medical Inc. Terminated

03/16/2020 Natural Remedies Active Male capsules Presence of Undeclared Tadalafil Natural Remedy Store Terminated

11/15/2021 SterRx, LLC SterRx products intended to be sterile Lack of sterility assurance SterRx, LLC

11/19/2021 American Screening Hand Sanitizer Hand sanitizer is packaged in 8 oz. containers that resemble water bottles posing a risk of consumption American Screening LLC

11/17/2021 Odor-Eaters® Oder Eaters spray products Due to the presence of benzene Odor-Eaters®, owned by Blistex Inc.

11/23/2021 Old Spice, Secret Old Spice and Secret Aerosol Sprays Due to the presence of benzene The Proctor & Gamble Company

12/03/2021 Gilead Veklury® (remdesivir 100 mg for injection) Presence of glass particulates Gilead Sciences Inc.

12/07/2021 Teligent Pharma, Inc. Lidocaine HCl Topical Solution USP 4%, 50ml Super potent Teligent Pharma, Inc.

12/07/2021 Edge Pharma, LLC All drugs compounded at Edge Pharma, LLC Process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety and quality of non-sterile products Edge Pharma, LLC

03/19/2020 CVS, Rhinall, Humist, more Nasal Products and Baby Oral Gels Microbial Contamination Product Quest Manufacturing LLC Terminated

12/02/2021 Sandoz Enoxaparin Sodium Injection Exposure to high temperatures may have impacted product effectiveness. Sandoz, Inc.

12/10/2021 Rompe Pecho Liquid Cold & Flu symptom relief Microbial contamination Efficient Laboratories, Inc

07/08/2020 Lupin Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg N-Nitrosodimethylamine (NDMA) Impurity Lupin Pharmaceuticals, Inc. Terminated

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