Bromfenac Ophthalmic Solution recall: Sterility Concern
Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.
Why was Bromfenac Ophthalmic Solution recalled?
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
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 #221211, Expiry: 09/30/2015
- Product
- Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.
- Recalling firm
- Bausch & Lomb, Inc.
- Quantity
- 13,995 Bottles
- Distribution
- U.S. Nationwide and Puerto Rico
- Recall date
- August 26, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)