Akorn, Inc.: Drug Recall
Recall #D-0156-2023 · 10/13/2022
Class II: Risk
Recall Details
- Recall Number
- D-0156-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Akorn, Inc.
- Status
- Ongoing
- Date Initiated
- 10/13/2022
- Location
- Gurnee, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,310,324 bottles
Reason for Recall
CGMP Deviations:
Product Description
Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
Distribution Pattern
Nationwide in the USA
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.