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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Detail

Product Description Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.
Recall Number D-1667-2012
Classification Class III
Code Info Lot #: JK9130, JM0925, Exp 05/12; JN6514, Exp 07/12; JN1125, JN1127, Exp 08/12; JR5780, JR5782, Exp 12/12.
Product Distributed Qty 963,407 bottles
Reason For Recall CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.

Event Detail

Event Id 62930
Product Type Drugs
Status Ongoing
Recalling Firm Apotex Corp.
City Weston
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-06-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico