Recalls / Class II
Class IID-1349-2015
Product
Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.
- Affected lot / code info
- Lot #221211, Expiry: 09/30/2015
Why it was recalled
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Recalling firm
- Firm
- Bausch & Lomb, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8500 Hidden River Pkwy, Tampa, Florida 33637-1014
Distribution
- Quantity
- 13,995 Bottles
- Distribution pattern
- U.S. Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-08-17
- FDA classified
- 2015-08-20
- Posted by FDA
- 2015-08-26
- Terminated
- 2017-04-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1349-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.