Bromfenac Ophthalmic Solution 0.09% recall: CGMP Deviations
Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7…
Why was Bromfenac Ophthalmic Solution 0.09% recalled?
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
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?
a) Lot #: KY8498, Expiry: 01/2016; b) Lot #: KY8496, Expiry: 01/2016; c) Lot #: MC5426, Expiry: 02/2016; Lot #: KZ2002, Expiry: 04/2016.
- Product
- Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7…
- Recalling firm
- Apotex Inc.
- Quantity
- 33,795 Bottles
- Distribution
- U.S. Nationwide.
- Recall date
- April 22, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)