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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 2381–2400 of 17,723 recalls

Class IIOngoing

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, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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, Inc.

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

April 26, 2023 · DrugView details →

DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.

Gadget Island, Inc

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

April 26, 2023 · DrugView details →

Class IIOngoing

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, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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

Akorn, Inc.

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

April 26, 2023 · DrugView details →

Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0.

Gadget Island, Inc

Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

April 26, 2023 · DrugView details →

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