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 Phar

FDA recall notice · announced October 10, 2012 · Caraco Pharmaceutical Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

Crystallization: Presence of crystals of Nimodipine within the capsule solution.

Notes

Distribution: One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts
Lot/code information: Lot: a) 3305.039B, Exp 07/13; b) 3305.039A, Exp 07/13
Quantity: a) 2424 Cartons b) 2675 Cartons
Status: Terminated
Products in this recall event:
- 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 (D-003-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.