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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Product Detail

Product Description 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.
Recall Number D-003-2013
Classification Class II
Code Info Lot: a) 3305.039B, Exp 07/13; b) 3305.039A, Exp 07/13
Product Distributed Qty a) 2424 Cartons b) 2675 Cartons
Reason For Recall Crystallization: Presence of crystals of Nimodipine within the capsule solution.

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 Letter
Distribution Pattern One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts