Drug 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 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.
D-0487-2015
Product summary
- Firm
- Apotex Inc.
- Event
- Event 70720
- Status
- Terminated
- Classification
- Class III
- Quantity
- 33,795 Bottles
- Official record key
drug-enforcement:D-0487-2015
Official wording
Reason: CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Code information: a) Lot #: KY8498, Expiry: 01/2016; b) Lot #: KY8496, Expiry: 01/2016; c) Lot #: MC5426, Expiry: 02/2016; Lot #: KZ2002, Expiry: 04/2016.
Distribution pattern: U.S. Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations