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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Event Detail

Event ID 65501
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 2013-05-21
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide and Puerto Rico

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 #s: a) 3305.036B, 3305.037B, Exp Jun-13; 3505.041B, Exp Sep-13; 3305.043B, Exp Nov-13; 3305.044B, Exp Dec-13; 3305.045B Mar-14. Lot #s: b) 3305.036A, 3305.037A, Exp Jun-13; 3305.038A, Exp Jul-13; 3305.040A, 3505.041A Exp Sep-13; 3305.042A, 3305.043A, Exp Nov-13; 3305.044A Dec-13. Class II Crystallization; crystallized nimopdipine 46387 Cartons D-687-2013