Bromfenac Ophthalmic Solution recalled over sterility concerns
- Recall date
- August 17, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Bausch & Lomb, Inc. recalls Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 3363…
- Recall number
- D-1349-2015
- FDA classification
- Class II
- Brand / firm
- Bausch & Lomb, Inc.
- Sold / distributed
- U.S. Nationwide and Puerto Rico
Why it was recalled
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.
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