Drug Enforcement D-003-2013

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

Status

Terminated

Classification

Class II

Report Date

October 10, 2012

Termination Date

November 19, 2013

Product Information

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.
Product quantity
a) 2424 Cartons b) 2675 Cartons
Reason for recall
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts

Location & Firm

Recalling firm
Caraco Pharmaceutical Laboratories Ltd.
Address
270 Prospect Plains Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-003-2013
Event ID
63031
Recall initiation date
August 21, 2012
Center classification date
October 3, 2012
Code info
Lot: a) 3305.039B, Exp 07/13; b) 3305.039A, Exp 07/13
More code info
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