FDA recall D-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

Reason for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2012-04-30

Report date

2012-08-08

Termination date

2013-09-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Toronto, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1439-2012