Home / Recalls / Akorn, Inc. / D-0813-2023

D-0813-2023 Class II Ongoing

Recalled by Akorn, Inc. — Gurnee, IL

Recall Details

Product Type
Drugs
Report Date
June 7, 2023
Initiation Date
April 26, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Ketorolac 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

Reason for Recall

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

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

All Lots

Other recalls by Akorn, Inc.

  • D-0835-2023 Class II — Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, S (April 26, 2023)
  • D-0840-2023 Class II — Rifampin Capsules USP, 150 mg, 30-count bottles, Rx Only, Sterile, Distributed b (April 26, 2023)
  • D-0858-2023 Class II — Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Opera (April 26, 2023)
  • D-0796-2023 Class II — Clobetasol Propionate Shampoo, 0.05%, 4oz (118 mL) bottles, Rx Only, Distribute (April 26, 2023)
  • D-0803-2023 Class II — Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by (April 26, 2023)
  • D-0833-2023 Class II — Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles, Rx Only, Manufactu (April 26, 2023)
  • D-0809-2023 Class II — HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscu (April 26, 2023)
  • D-0821-2023 Class II — Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: (April 26, 2023)
  • D-0820-2023 Class II — Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles, Rx Only, Manufactured by: (April 26, 2023)
  • D-0828-2023 Class II — Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use (April 26, 2023)