Recalls / Class II
Class IID-852-2013
Product
Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL 33326; NDC 60505-0565-1; UPC 3 60505 05651 4.
- Affected lot / code info
- Lot #: JX1877, Exp 06/13
Why it was recalled
Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date.
Recalling firm
- Firm
- Apotex Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 380 Elgin Mills Rd East, N/A, Richmond Hill, N/A N/A, Canada
Distribution
- Quantity
- 50,982 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-06-25
- FDA classified
- 2013-08-08
- Posted by FDA
- 2013-08-14
- Terminated
- 2016-04-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-852-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.