Drug product
Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.
D-1349-2015
Product summary
- Event
- Event 71896
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,995 Bottles
- Official record key
drug-enforcement:D-1349-2015
Official wording
Reason: Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Code information: Lot #221211, Expiry: 09/30/2015
Distribution pattern: U.S. Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility