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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Product Detail

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

Event Detail

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