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
Reported: October 13, 2021 Initiated: October 4, 2021 #D-0004-2022
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
Reason for Recall
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Details
- Recalling Firm
- Akorn, Inc.
- Units Affected
- 10,210 bottles
- Distribution
- Distributed Nationwide in the USA
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Akorn, Inc.. Units affected: 10,210 bottles.
Why was this product recalled? ▼
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 13, 2021. Severity: Moderate. Recall number: D-0004-2022.
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