May 2013 FDA Recall Drug by Sun Pharmaceutical Industries Inc.
D-687-2013 - Crystallization; crystallized nimodipine

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc. on May 21, 2013 for the product Drug. The FDA reported the reason for recall as crystallization; crystallized nimodipine. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-687-2013

Reason for Recall
Crystallization; crystallized nimodipine
Initiated
05-21-2013
Reported
07-17-2013
Quantity
46387 Cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65501
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.
Sun Pharmaceutical Industries Inc.
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.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-25-2014
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# s: a) 3305.036B, 3305.037B, Exp Jun-13; 3505.041B, Exp Sep-13; 3305.043B, Exp Nov-13; 3305.044B, Exp Dec-13; 3305.045B Mar-14.
Lot# s: b) 3305.036A, 3305.037A, Exp Jun-13; 3305.038A, Exp Jul-13; 3305.040A, 3505.041A Exp Sep-13; 3305.042A, 3305.043A, Exp Nov-13; 3305.044A Dec-13.