FDAFDA · Food and drugs·Recall number D-0004-2022
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
Published October 13, 2021 · Recall initiated: October 4, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn, Inc.
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lot 0B61A, Exp 01/31/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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