FDA-Drug2012-10-10Class II

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.

Caraco Pharmaceutical Laboratories Ltd.
Hazard

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

Sold states
One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts
Affected count
a) 2424 Cartons b) 2675 Cartons
Manufactured in
270 Prospect Plains Rd, N/A, Cranbury, NJ, United States
Products
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.

Official notice

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

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