Drug product
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.
D-003-2013
Product summary
- Event
- Event 63031
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 2424 Cartons b) 2675 Cartons
- Official record key
drug-enforcement:D-003-2013
Official wording
Reason: Crystallization: Presence of crystals of Nimodipine within the capsule solution.
Code information: Lot: a) 3305.039B, Exp 07/13; b) 3305.039A, Exp 07/13
Distribution pattern: One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts
Derived failure modes
-
Unknown
Crystallization: Presence of crystals of Nimodipine within the capsule solution.