Akorn, Inc.

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
D-0851-2023Class IITobramycin Ophthalmic Solution, USP 0.3%, 5mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake FApril 26, 2023
D-0793-2023Class IICimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating ComApril 26, 2023
D-0781-2023Class IIAcetic Acid Otic Solution, 15 mL per bottle, Rx only, Distributed by: Akorn Operating Company LLC, GApril 26, 2023
D-0859-2023Class IIMidazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vialApril 26, 2023
D-0864-2023Class IITropicamide Ophthalmic Solution, USP 0.1%, 15 mL bottles, Rx only, Distributed by: Akorn Operating CApril 26, 2023
D-0862-2023Class IIPilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed 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-0813-2023Class IIKetorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile, packaged in a) 3mL bottles, b bottles) 5 April 26, 2023
D-0839-2023Class IIProparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn OperatApril 26, 2023
D-0828-2023Class IIMidazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx April 26, 2023
D-0840-2023Class IIRifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed by: Akorn Operating CApril 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-0820-2023Class IILevofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake FoApril 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-0803-2023Class IIFerrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating CoApril 26, 2023
D-0835-2023Class IIPilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed April 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-0796-2023Class IIClobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distributed by: Akorn OperatinApril 26, 2023
D-0800-2023Class IIDiuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial, Rx Only, Distributed by: AkoApril 26, 2023