Betaxolol Ophthalmic Solution recall: Sterility Concern
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…
Why was Betaxolol Ophthalmic Solution recalled?
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 0B61A, Exp 01/31/2022
- 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…
- Recalling firm
- Akorn, Inc.
- Quantity
- 10,210 bottles
- Distribution
- Distributed Nationwide in the USA
- Recall date
- October 13, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)