Betaxolol Ophthalmic Solution recall: CGMP Deviations
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…
Why was Betaxolol Ophthalmic Solution recalled?
CGMP Deviations:
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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: 1A08A, EXP 12/31/2022
- 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…
- Recalling firm
- Akorn, Inc.
- Quantity
- 6,273 bottles
- Distribution
- Nationwide in the USA
- Recall date
- January 25, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)