Akorn, Inc.

FDA Regulatory Profile

Summary

Total Recalls
192
510(k) Clearances
0
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0835-2023Class IIPilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed April 26, 2023
D-0796-2023Class IIClobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn OperatinApril 26, 2023
D-0809-2023Class IIHydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous UApril 26, 2023
D-0833-2023Class IIOlopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc.,April 26, 2023
D-0817-2023Class IILevocarnitine Oral Solution, USP, 118 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 6April 26, 2023
D-0840-2023Class IIRifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating CApril 26, 2023
D-0821-2023Class IILidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CApril 26, 2023
D-0854-2023Class IIValproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles, Rx only, Distributed by: Akorn OperatApril 26, 2023
D-0858-2023Class IICalcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., April 26, 2023
D-0856-2023Class IIXOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx oApril 26, 2023
D-0790-2023Class IICalcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., April 26, 2023
D-0787-2023Class IIAzelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray, Rx Only, For Intranasal Use Only, April 26, 2023
D-0845-2023Class IISodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles, Distributed by: Akorn OperatinApril 26, 2023
D-0788-2023Class IIAK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile, Rx Only, FApril 26, 2023
D-0860-2023Class IIOlopatadine HCl Ophthalmic Solution, USP, 0.2%, 5mL bottles, Rx Only, Sterile, Manufactured by: AkorApril 26, 2023
D-0820-2023Class IILevofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake FoApril 26, 2023
D-0861-2023Class IIPilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles, Rx Only, Sterile, Distributed April 26, 2023
D-0803-2023Class IIFerrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating CoApril 26, 2023
D-0824-2023Class IILidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed bApril 26, 2023
D-0806-2023Class IIGranisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For IntravenApril 26, 2023