Betaxolol Ophthalmic Solution Recalled for Sterility Failure
Akorn, Inc. is recalling Betaxolol Ophthalmic Solution, USP 0.5% due to confirmed sterility failure detected during stability testing. The affected lot was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall meets FDA Class II classification criteria for a sterile drug product with confirmed sterility failure and microbial contamination, which could result in serious adverse health consequences for patients, particularly those with compromised immune systems or underlying conditions.
Plain-English summary
Akorn, Inc. is recalling Betaxolol Ophthalmic Solution, USP, 0.5% (Betaxolol HCl 5.6 mg/mL) in 5 mL dropper bottles because a confirmed sterility failure was identified during stability testing at the 12-month time point. This is a sterile drug product, and microbial contamination poses a risk to patients using the affected medication.
The recalled product includes Carton NDC 17478-705-10 and Bottle NDC 17478-705-11, Lot 0B61A with expiration date 01/31/2022. Approximately 10,210 bottles were distributed nationwide in the USA.
Patients currently using this product should consult with their healthcare provider or pharmacist immediately. Healthcare providers and pharmacies should stop dispensing the affected lot and quarantine any remaining stock.
The recalled product
- 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
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 10,210
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 0B61A
- Exp 01/31/2022
Distribution
Distributed nationwide across the United States.
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