Recalls / Class III
Class IIID-0487-2015
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.
- Affected 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.
Why it was recalled
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Recalling firm
- Firm
- Apotex Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Drive, N/A, Toronto, N/A N/A, Canada
Distribution
- Quantity
- 33,795 Bottles
- Distribution pattern
- U.S. Nationwide.
Timeline
- Recall initiated
- 2015-02-12
- FDA classified
- 2015-04-15
- Posted by FDA
- 2015-04-22
- Terminated
- 2016-12-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0487-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.