FDA-Drug2015-04-22Class III
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.
Apotex Inc.
Hazard
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Sold states
U.S. Nationwide.
Affected count
33,795 Bottles
Manufactured in
150 Signet Drive, N/A, Toronto, N/A, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0487-2015Don't want to check this manually?
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