D-1349-2015 Class II Terminated
FDA drug recall D-1349-2015 was initiated by Bausch & Lomb, Inc. on August 17, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Failed preservative effectiveness testing. The recall status is terminated (terminated April 7, 2017). Affected quantity: 13,995 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 26, 2015
- Initiation Date
- August 17, 2015
- Termination Date
- April 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,995 Bottles
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.
Distribution Pattern
U.S. Nationwide and Puerto Rico
Code Information
Lot #221211, Expiry: 09/30/2015