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 IIFluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIFerrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, 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 IIEphedrine 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
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIDOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL Unit Dose cups, 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 IIDiuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, 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 IIDicyclomine 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
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIDetomiSed (detomidine hydrochloride) packaged in a) 5mL and b)20mL vials, 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 IICromolyn Sodium Ophthalmic Solution, USP, 4%, 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 IIClobetasol Propionate Shampoo, 0.05%, 4oz (118 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 IIClobetasol Propionate Ointment, USP, 0.05%, 15 g 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 IIClobetasol Propionate Cream, USP, 0.05%, packaged in a) 15g tubes, b) 30g tubes, and c) 60g 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 IICimetidine HCl Oral Solution 300mg/5mL, 237 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 IICiclopirox Topical Solution 8% (Nail Lacquer), 6.6 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 IICetrorelix 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
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IICalcitriol Injection 1 mcg/mL, 1 mL ampules 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 IICalcipotriene Topical Solution, 0.005% (Scalp Solution), 60 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 IIAK-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
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIAzelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use 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 IIArtificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes, 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 IIArtificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use 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 IIApraclonidine 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
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIAlbuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, 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 IIAcyclovir Oral Suspension, 200mg/5mL, 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 IIAcetic Acid Otic Solution, 15 mL per bottle, 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 IIAcetaminophen & 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
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- 2023-06-07FDA-DrugClass IIAtropine 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
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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