August 2012 FDA Recall Drug by Caraco Pharmaceutical Laboratories Ltd.
D-003-2013 - Crystallization

This Class II drug recall was voluntarily initiated by Caraco Pharmaceutical Laboratories Ltd. on August 21, 2012 for the product Drug. The FDA reported the reason for recall as crystallization. The product was distributed in One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts and the recall is currently terminated.

Recall Number: D-003-2013

Reason for Recall
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
Initiated
08-21-2012
Reported
10-10-2012
Quantity
a) 2424 Cartons b) 2675 Cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63031
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Caraco Pharmaceutical Laboratories Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
One direct account - Caraco Pharmaceutical Labroatories, LTD Detroit, Michigan 78 sub accounts
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-19-2013
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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