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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Fentanyl Citrate Injection, USP 100 mcg/2mL (50 mcg/mL), Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Prednisolone Oral Solution, USP, 15 mg/5 mL, packaged in a) 240 mL and b) 480 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules, Rx only, Manufactured by: Akorn, Inc, Lake Forest, IL 60045. ALL NDCs

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Tobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

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.

Denison Pharmaceuticals

Class I - Dangerous

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

May 3, 2023 Other Drugs Nationwide View Details →

Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. ALL NDCs

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

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

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

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

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Lidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Other Drugs Nationwide View Details →

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

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 118 mL bottles, b) 473 mL bottles and c) 100 unit dose cups, Rx Only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →

Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Akorn

Class I - Dangerous

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Apr 26, 2023 Prescription Drugs Nationwide View Details →