BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41
Reported: February 6, 2019 Initiated: January 24, 2019 #D-0422-2019
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.
Details
- Recalling Firm
- Sun Pharmaceutical Industries, Inc.
- Units Affected
- 69840 bottles
- Distribution
- Nationwide within the United States
- Location
- Cranbury, NJ
Frequently Asked Questions
What product was recalled? ▼
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 69840 bottles.
Why was this product recalled? ▼
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 6, 2019. Severity: Moderate. Recall number: D-0422-2019.
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