Class II
Terminated
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.
This recall has been terminated (originally issued October 10, 2012).
- Recall Initiated
- August 21, 2012
- Posted
- October 10, 2012
- Recall Number
- D-003-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 2424 Cartons b) 2675 Cartons
- Firm Location
- Cranbury, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
Distribution
One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts
Lot / Code Info
Lot: a) 3305.039B, Exp 07/13; b) 3305.039A, Exp 07/13
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