Reported Feb 6, 2019 · Terminated
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries,…
Sun Pharmaceutical Industries, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sun Pharmaceutical Industries, Inc. · 270 Prospect Plains Rd · Cranbury, NJ · 08512-3605
Is this the product you have?
- BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only
- Distributed bySun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41
- Lot codes and dates
Lot #: V18E01Exp. 05/2020
- Amount recalled
- 69840 bottles
Where it was sold
- Nationwide
Why it was recalled
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Sun Pharmaceutical Industries, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.