Class II
Terminated
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
- Company
- Akorn, Inc.
- Recall Initiated
- October 4, 2021
- Posted
- October 13, 2021
- Recall Number
- D-0004-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 10,210 bottles
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Distribution
Distributed Nationwide in the USA
Lot / Code Info
Lot 0B61A, Exp 01/31/2022
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