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-687-2013
Product summary
- Event
- Event 65501
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46387 Cartons
- Official record key
drug-enforcement:D-687-2013
Official wording
Reason: Crystallization; crystallized nimodipine
Code information: 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.
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Crystallization; crystallized nimodipine