Recalls / Class II
Class IID-0009-2016
Product
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.
- Affected lot / code info
- Lot #: a) MF0537, Exp 07/2016; b) MF8090, MF0532, Exp 07/2016
Why it was recalled
Lack of Assurance of Sterility: Failed preservative effectiveness testing
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
- 5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-08-25
- FDA classified
- 2015-10-09
- Posted by FDA
- 2015-10-21
- Terminated
- 2022-06-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0009-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.