FDA recall D-003-2013

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.

Distribution

One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts

Key facts

Status

Terminated

Initiation date

2012-08-21

Report date

2012-10-10

Termination date

2013-11-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-003-2013