Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.
Reported: August 26, 2015 Initiated: August 17, 2015 #D-1349-2015
Product Description
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.
Details
- Recalling Firm
- Bausch & Lomb, Inc.
- Units Affected
- 13,995 Bottles
- Distribution
- U.S. Nationwide and Puerto Rico
- Location
- Tampa, FL
Frequently Asked Questions
What product 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.. Recalled by Bausch & Lomb, Inc.. Units affected: 13,995 Bottles.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 26, 2015. Severity: Moderate. Recall number: D-1349-2015.
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