D-0422-2019 Class II Terminated
FDA drug recall D-0422-2019 was initiated by Sun Pharmaceutical Industries, Inc. on January 24, 2019 and is designated Class II. Reason for recall: Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance. The recall status is terminated (terminated February 22, 2021). Affected quantity: 69840 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 6, 2019
- Initiation Date
- January 24, 2019
- Termination Date
- February 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69840 bottles
Product Description
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.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: V18E01, Exp. 05/2020