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U.S. Department of Health and Human Services

Enforcement Report - Week of June 10, 2015

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Product Detail

Product Description Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540. NDC 66394-041-06
Recall Number D-1115-2015
Classification Class III
Code Info Lot #: DP3841, DP5237, DP5238, DP5238A, DP5238B Exp 05/2015; DR7807, DR9954, DR9959, DV5838, Exp 07/2015.
Product Distributed Qty 1,023,430 units
Reason For Recall Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.

Event Detail

Event Id 71055
Product Type Drugs
Status Ongoing
Recalling Firm Sandoz, Inc
City Princeton
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2015-04-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide