Akorn, Inc.: Drug Recall
Recall #D-0004-2022 · 10/04/2021
Class II: Risk
Recall Details
- Recall Number
- D-0004-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Akorn, Inc.
- Status
- Terminated
- Date Initiated
- 10/04/2021
- Location
- Lake Forest, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,210 bottles
Reason for Recall
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Product Description
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11
Distribution Pattern
Distributed 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.