Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Tropicamide Ophthalmic Solution, USP 0.1%, 15 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 Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, Rx Only, Manufactured by: Akorn Inc.
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, Manufact
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Calcitriol Injection 2 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 Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LL
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by:
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Valproic Acid Oral Solution, USP, 250mg/5mL, 473 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 Tropicamide Ophthalmic Solution, USP 0.5%, 15 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 Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. -
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Fores
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15m
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufac
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For I
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial 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 Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurne
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Sodium Chloride Ophthalmic Ointment, USP, 5%, 3.5g tubes, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. AL
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by:
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count bottles, Rx Only, Distributed by: Akorn
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, 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 Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 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 Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, 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 Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
June 7, 2023DrugsFDA
Akorn, Inc. recalls Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating
Hazard: CGMP Deviations: Firm went out of business and could no longer continue stability studies.