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 | Letter |
| 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 |
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