Drug product
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41
D-0422-2019
Product summary
- Event
- Event 81958
- Status
- Terminated
- Classification
- Class II
- Quantity
- 69840 bottles
- Official record key
drug-enforcement:D-0422-2019
Official wording
Reason: Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Code information: Lot #: V18E01, Exp. 05/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
lack of sterility