drugs Class III Updated 2015-04-22

Apotex Inc. recalls Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apote

Recalled 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.

Hazard / Issue

CGMP Deviations: Product excipient was not re-tested at the appropriate date.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: a) Lot #: KY8498, Expiry: 01/2016; b) Lot #: KY8496, Expiry: 01/2016; c) Lot #: MC5426, Expiry: 02/2016; Lot #: KZ2002, Expiry: 04/2016.
View official government recall

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