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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, 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 →

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

SSM Health Care St. Louis

Class I - Dangerous

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.

May 9, 2023 Prescription Drugs View Details →

Cimetidine HCl Oral Solution 300mg/5mL, 237 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 →

Hydromorphone Hydrochloride Injection, USP, 50mg/5mL (10 mg/mL) packaged in a) 1 mL ampules, b) 5 mL ampules, c) 50 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 →

Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.

Denison Pharmaceuticals

Class I - Dangerous

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

May 3, 2023 Other Drugs Nationwide View Details →

XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, 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 →

Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 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 →

Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, 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 →

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.

Denison Pharmaceuticals

Class I - Dangerous

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

May 3, 2023 Other Drugs Nationwide View Details →

Rifampin Capsules USP, 150 mg, 30-count 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 →

Sodium DIURIL (chlorothiazide sodium), 0.5g/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 →

Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, 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, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose 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 →

Moxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 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 →

DetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, 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 →

Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 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 →

Promethazine HCl Oral Solution, USP, 6.25 mg/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 →

Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company- 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 →

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 mL, and c)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 →

Clobetasol Propionate Shampoo, 0.05%, 4oz (118 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 →