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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Event Detail

Event ID 62574
Product Type Drugs
Status Ongoing
Recalling Firm Apotex Inc.
City Toronto
Country CA
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-30
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide and Puerto Rico

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lot #s: JN1060, JN1061, JN1062, Exp 06/12 Class II Presence of Particulate Matter: Lots identified in this recall notification may contain small particulates. 119,794 Bottles D-1439-2012