Class II
Terminated
Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
- Company
- Apotex Inc.
- Recall Initiated
- August 25, 2015
- Posted
- October 21, 2015
- Recall Number
- D-0009-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)
- Firm Location
- Toronto, Canada
Reason for Recall
Lack of Assurance of Sterility: Failed preservative effectiveness testing
Distribution
Nationwide
Lot / Code Info
Lot #: a) MF0537, Exp 07/2016; b) MF8090, MF0532, Exp 07/2016
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