June 7, 2023DrugsFDA
Akorn, Inc. recalls Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, Rx Only, Distributed by: Akorn Op
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, Rx Only, Distributed by: Akorn Operating Compa
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gur
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee,
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Clobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g tubes, Rx Only, Distributed
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee,
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., G
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray which contains: 1 vial with lyophiliz
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. A
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating Compan
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, For Ophthalmic Use On
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, Manufactured by: Hi-
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, Distributed by: Akorn Operating Company LLC
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed by: Akorn Operating Company LLC,
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Apraclonidine Ophthalmic Solution 0.5%, packaged in a) 5mL and b) 10 mL bottles, Rx only, Sterile, For Topical Ophthalmi
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC,
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Acyclovir Oral Suspension, 200mg/5mL, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Acetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. AL
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL, packaged in a) 473mL bottles and b) 40 UD cups, Rx only,
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bo
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
New England Life Care, Inc. dba Advanced Compounding Solutions recalls Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions,
Hazard: Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
June 7, 2023DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Wa
Hazard: Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
June 7, 2023DrugsFDA
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalls HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsou
Hazard: 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.
June 7, 2023DrugsFDA
Denison Pharmaceuticals, LLC recalls Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118
Hazard: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
June 7, 2023DrugsFDA
Denison Pharmaceuticals, LLC recalls Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL OZ (60 mL) bottle, Distributed by: Cara Inc
Hazard: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
June 7, 2023DrugsFDA
Denison Pharmaceuticals, LLC recalls Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota
Hazard: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
June 7, 2023DrugsFDA
Denison Pharmaceuticals, LLC recalls Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle
Hazard: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
May 31, 2023DrugsFDA
Revive Rx LLC dba Revive Rx Pharmacy recalls Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx,
Hazard: Sub-potent Drug
May 31, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distribute
Hazard: Labeling: Incorrect or Missing Package Insert