Betaxolol ophthalmic solution recalled for manufacturing process violations
Akorn, Inc. is voluntarily recalling Betaxolol ophthalmic solution (6,273 bottles, lot 1A08A, exp. 12/31/2022) due to manufacturing deviations. Consumers should consult their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a sterile ophthalmic solution due to manufacturing practice deviations, which represents a risk-of-harm product. No illnesses or injuries have been reported, and the potential harm is theoretical, placing it at the upper bound of moderate-to-high severity per the rubric.
Plain-English summary
Akorn, Inc. is voluntarily recalling Betaxolol Ophthalmic Solution, USP 0.5%, a prescription eye drop medication supplied in 5 mL bottles. The recall encompasses 6,273 bottles with lot number 1A08A and expiration date of December 31, 2022.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations in the manufacturing process. These deviations may impact the quality and safety characteristics of the product.
The affected medication was distributed nationwide in the United States. Patients and healthcare providers who have bottles from this lot should take appropriate action.
Consumers should not use bottles from lot 1A08A and should consult their healthcare provider regarding alternative treatment options or proper disposal of the medication.
The recalled product
- Product
- Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic
- Hazard
- contamination
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: 1A08A
- EXP 12/31/2022
Distribution
Distributed nationwide across the United States.
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