Class III
Terminated
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.
- Company
- Apotex Inc.
- Recall Initiated
- February 12, 2015
- Posted
- April 22, 2015
- Recall Number
- D-0487-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 33,795 Bottles
- Firm Location
- Toronto, Canada
Reason for Recall
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Distribution
U.S. Nationwide.
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.
More recalls by Apotex Inc.
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