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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 2401–2420 of 17,723 recalls

Class IIOngoing

Levetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, 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

Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, 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

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, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Hydrocortisone and Acetic Acid Otic Solution, USP, 10 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

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, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 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

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, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

Cimetidine HCl Oral Solution 300mg/5mL, 237 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

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, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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, 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 4%, 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

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

Rifampin Capsules USP, 150 mg, 30-count 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 →

NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.

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

Sodium DIURIL (chlorothiazide sodium), 0.5g/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

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, Inc.

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

April 26, 2023 · DrugView details →

Class IIOngoing

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, Inc.

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

April 26, 2023 · DrugView details →

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