Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.

FDA recall notice · announced August 26, 2015 · Bausch & Lomb

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.

Reason for recall

Lack of Assurance of Sterility: Failed preservative effectiveness testing.

Notes

Distribution: U.S. Nationwide and Puerto Rico
Lot/code information: Lot #221211, Expiry: 09/30/2015
Quantity: 13,995 Bottles
Status: Terminated
Products in this recall event:
- Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01. (D-1349-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.