April 2014 FDA Recall Drug by Caraco Pharmaceutical Laboratories, Ltd.
D-1407-2014 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Caraco Pharmaceutical Laboratories, Ltd. on April 9, 2014 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in OH and the recall is currently terminated.

Recall Number: D-1407-2014

Reason for Recall
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Initiated
04-09-2014
Reported
07-02-2014
Quantity
200 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68209
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
OH
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-29-2014
Product Description About Product Description
Full technical description of the product.
Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40

Batch or Lot Expiration Information

Lot# JKM7188A