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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Event Detail

Event ID 63031
Product Type Drugs
Status Ongoing
Recalling Firm Sun Pharmaceutical Industries Inc.
City Cranbury
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-21
Initial Firm Notification of
Consignee or Public
Distribution Pattern One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc. Lot: a) 3305.039B, Exp 07/13; b) 3305.039A, Exp 07/13 Class II Crystallization: Presence of crystals of Nimodipine within the capsule solution. a) 2424 Cartons b) 2675 Cartons D-003-2013