Drug 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
D-1439-2012
Product summary
- Firm
- Apotex Inc.
- Event
- Event 62574
- Status
- Terminated
- Classification
- Class II
- Quantity
- 119,794 Bottles
- Official record key
drug-enforcement:D-1439-2012
Official wording
Reason: Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
Code information: Lot #s: JN1060, JN1061, JN1062, Exp 06/12
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter