Akorn, Inc.: Drug Recall
Recall #D-0813-2023 · 04/26/2023
Class II: Risk
Recall Details
- Recall Number
- D-0813-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Akorn, Inc.
- Status
- Ongoing
- Date Initiated
- 04/26/2023
- Location
- Gurnee, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Reason for Recall
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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
Distribution Pattern
Nationwide in the USA and Puerto Rico
Other Recalls by Akorn, Inc.
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.