PlainRecalls
FDA Drug Moderate 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.

Reported: July 17, 2013 Initiated: May 21, 2013 #D-687-2013

Product Description

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; crystallized nimodipine

Details

Units Affected
46387 Cartons
Distribution
Nationwide and Puerto Rico
Location
Cranbury, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Sun Pharmaceutical Industries Inc.. Units affected: 46387 Cartons.
Why was this product recalled?
Crystallization; crystallized nimodipine
Which agency issued this recall?
This recall was issued by the FDA Drug on July 17, 2013. Severity: Moderate. Recall number: D-687-2013.