Drug product
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
D-0004-2022
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 88823
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,210 bottles
- Official record key
drug-enforcement:D-0004-2022
Official wording
Reason: Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Code information: Lot 0B61A, Exp 01/31/2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial Contamination