July 2013 FDA Recall Drug by Torrent Pharma Inc (D-830-2013 - Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.)

This Class II drug recall was voluntarily initiated by Torrent Pharma Inc on July 22, 2013 for the product Drug. The FDA reported the reason for recall as defective container; this action is being taken as a precautionary measure due to the product being re-packaged in the u.s. using a filler material that (removes or blocks) less moisture than what is approved in the application.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-830-2013

Reason for Recall
Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.
Initiated
07-22-2013
Reported
08-07-2013
Quantity
18,721 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65780
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.
Torrent Pharma 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-31-2014
Product Description About Product Description
Full technical description of the product.
Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by: Torrent Pharmaceuticals Ltd., Indrad-382 721, Dist. Mehsana India, NDC 66993-463-30

Batch or Lot Expiration Information

Lot# : BS392004A, Exp: 09/2014