Drug and pharmaceutical recalls

17623 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2023-06-07FDA-DrugAkorn, Inc.Class II
Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophilized powder for reconstitution, 1 pre-filled syringe with diluent, 1 20-gauge needle, 1 27-gauge needle, Sterile - For subcutaneous use only, Rx Only, Manufactured by: GP Pharm S.A. Barcelona, Spain (ESP) -08777, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-Tech Pharmacal Co., INC., Amityville, NY 11701. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugAkorn, Inc.Class II
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
2023-06-07FDA-DrugNew England Life Care, Inc. dba Advanced Compounding SolutionsClass III
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25
Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
2023-06-07FDA-DrugFresenius Medical Care Holdings, Inc.Class II
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
2023-06-07FDA-DrugSSM Health Care St. Louis DBA SSM St. Clare Health CenterClass II
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
2023-06-07FDA-DrugDenison Pharmaceuticals, LLCClass II
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
2023-06-07FDA-DrugDenison Pharmaceuticals, LLCClass II
Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Incorporated, 333 Strawberry Field Road, Warwick, RI 05886. NDC 70309-080-02
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
2023-06-07FDA-DrugDenison Pharmaceuticals, LLCClass II
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
2023-06-07FDA-DrugDenison Pharmaceuticals, LLCClass II
Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
2023-05-31FDA-DrugRevive Rx LLC dba Revive Rx PharmacyClass II
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64.
Sub-potent Drug
2023-05-31FDA-DrugTeva Pharmaceuticals USA IncClass III
Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28
Labeling: Incorrect or Missing Package Insert
2023-05-31FDA-DrugTeva Pharmaceuticals USA IncClass III
Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28
Labeling: Incorrect or Missing Package Insert
2023-05-31FDA-DrugTeva Pharmaceuticals USA IncClass III
Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28
Labeling: Incorrect or Missing Package Insert
2023-05-31FDA-DrugTeva Pharmaceuticals USA IncClass III
Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28
Labeling: Incorrect or Missing Package Insert
2023-05-31FDA-DrugTeva Pharmaceuticals USA IncClass III
Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28
Labeling: Incorrect or Missing Package Insert

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