PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 8, 2012 Initiated: April 30, 2012 #D-1439-2012

Product Description

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

Reason for Recall

Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.

Details

Recalling Firm
Apotex Inc.
Units Affected
119,794 Bottles
Distribution
Nationwide and Puerto Rico
Location
Toronto, N/A

Frequently Asked Questions

What product was recalled?
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. Recalled by Apotex Inc.. Units affected: 119,794 Bottles.
Why was this product recalled?
Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 8, 2012. Severity: Moderate. Recall number: D-1439-2012.