Bromfenac Ophthalmic Solution 0.09% recall: Sterility Concern
Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
Why was Bromfenac Ophthalmic Solution 0.09% 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 #: a) MF0537, Exp 07/2016; b) MF8090, MF0532, Exp 07/2016
- Product
- Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
- Recalling firm
- Apotex Inc.
- Quantity
- 5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)
- Distribution
- Nationwide
- Recall date
- October 21, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)