Recalls / Class II
Class IID-1439-2012
Product
Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9
- Affected lot / code info
- Lot #s: JN1060, JN1061, JN1062, Exp 06/12
Why it was recalled
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
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
- 119,794 Bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2012-04-30
- FDA classified
- 2012-08-02
- Posted by FDA
- 2012-08-08
- Terminated
- 2013-09-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1439-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.