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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Megestrol Acetate Oral Suspension, USP 40 mg/mL, 240 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 →

Ferrous Sulfate Iron Supplement Drops, packaged in 50 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 →

Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For 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 Other Drugs Nationwide View Details →

Olopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, 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 →

Clobetasol Propionate Ointment, USP, 0.05%, 15 g 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 →

Rifampin Capsules USP, 300 mg, packaged in a) 30 count bottles and b) 60 count 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 →

Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use, 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 →

Ropivacaine Hydrochloride Injection USP, 0.2%, 200mg/100 mL (2 mg/mL), 100 mL Vial, 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 →

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

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 →

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

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 Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, 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 →

G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant, Cherry Flavor Sugar & Alcohol Free, packaged in a bottle Net Content: 30 mL (1 oz.) further packaged in a carton, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-655-01

Novis PR, LLC

Class I - Dangerous

Product mix-up: incorrect product was found inside the G-Supress DX product carton.

Apr 20, 2023 Other Drugs View Details →

Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use, 1 mL vials, 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 →

Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 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 →

IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, 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 →

Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL 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 →

Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 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 →

Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL bottles, and c) 480 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 →

Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules, 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 →

Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, 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 →