Recalls / Class II
Class IID-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
- Brand name
- Bromsite
- Generic name
- Bromfenac
- Active ingredient
- Bromfenac Sodium
- Route
- Ophthalmic
- NDC
- 49708-754
- FDA application
- NDA206911
- Affected lot / code info
- Lot #: V18E01, Exp. 05/2020
Why it was recalled
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, N/A, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 69840 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-01-24
- FDA classified
- 2019-01-30
- Posted by FDA
- 2019-02-06
- Terminated
- 2021-02-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0422-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.