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Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5...

FDA Recall #D-003-2013 — Class II — August 21, 2012

Recall #D-003-2013 Date: August 21, 2012 Classification: Class II Status: Terminated

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: Presence of crystals of Nimodipine within the capsule solution.

Recalling Firm

Caraco Pharmaceutical Laboratories Ltd. — Cranbury, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

a) 2424 Cartons b) 2675 Cartons

Distribution

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

Code Information

Lot: a) 3305.039B, Exp 07/13; b) 3305.039A, Exp 07/13

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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