Drug recall D-0422-2019
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
Reason for recall
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Lots and codes
Lot #: V18E01, Exp. 05/2020
Recall details
- Recalling firm
- Sun Pharmaceutical Industries, Inc., Cranbury, NJ
- Quantity
- 69840 bottles
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 24, 2019
- Terminated
- February 22, 2021
Related products
- Bromsite – drug information
- NDC 49708-754 Bromsite 0.075% · Bromfenac Sodium .76 mg/mL · Sun Pharmaceutical Industries, Inc.