FDAFDA · Food and drugs·Recall number D-1349-2015
Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.
Published August 26, 2015 · Recall initiated: August 17, 2015
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
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bausch & Lomb, Inc.
- Distributor
- U.S. Nationwide and Puerto Rico
- Lot
- Lot #221211, Expiry: 09/30/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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