Reported Oct 13, 2021 · Terminated
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile,…
Akorn, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Akorn, Inc. · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862
Is this the product you have?
- Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile
- Manufactured byAkorn, Inc., Lake Forest, IL 60045
- Carton NDC
17478-705-10Bottle NDC 17478-705-11
- Lot codes and dates
Lot 0B61AExp 01/31/2022
- Amount recalled
- 10,210 bottles
Where it was sold
- Nationwide
Why it was recalled
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
This product could cause temporary or reversible health problems — stop using it.
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