Akorn, Inc.
86 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Akorn, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-06-07FDA-DrugClass IIOxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIOlopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIOlopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IINeomycin & Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, 3.5 g tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IINaloxone 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
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIMoxifloxacin HCl Ophthalmic Solution, USP, 0.5%, 3 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIMidazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIMegestrol Acetate Oral Suspension, USP 40 mg/mL, 240 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IILorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IILorazepam Injection, USP 2 mg/mL vial, 1 mL vials, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IILidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IILidocaine HCl Jelly USP, 2%, 5mL tubes, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IILidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IILidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IILevofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IILevofloxacin 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
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IILevofloxacin Injection 500mg/20 mL (25 mg/mL), For Intravenous Infusion, packaged in a) 20mL vials and b) 30 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IILevocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IILevetiracetam Oral Solution 100 mg/mL (100 mg/mL), 473 mL, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IILactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IILactulose Solution, USP (Oral), 10g/15 mL, packaged in a) 15mL bottles, b) 30 mL bottles, c) 473 mL bottles, and d) 946 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIKetorolac 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
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIIC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIHydromorphone 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
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIHydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIHydrALAZINE 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
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIGuaifenesin 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
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIGuaiatussin 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
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIGranisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIGonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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