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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL 33326; NDC 60505-0565-1; UPC 3 60505 05651 4.
Recall Number D-852-2013
Classification Class II
Code Info Lot #: JX1877, Exp 06/13
Product Distributed Qty 50,982 bottles
Reason For Recall Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date.

Event Detail

Event Id 65882
Product Type Drugs
Status Ongoing
Recalling Firm Apotex Inc
City Richmond Hill
Country CA
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide