FDAFDA · Food and drugs·Recall number D-0422-2019
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41
Published February 6, 2019 · Recall initiated: January 24, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BROMSITE
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot #: V18E01, Exp. 05/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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