Apotex Inc. recalls Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle,
Recalled April 22, 2015 · FDA recall D-0487-2015 · Apotex
Hazard
CGMP Deviations: Product excipient was not re-tested at the appropriate date. · FDA Class III
Units
33,795 Bottles
Sold at
U.S. Nationwide.
Description
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Product
Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326. Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.
Manufacturer(s)
Apotex Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →