Product Detail

Product Description 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

Recall Number D-830-2013

Classification Class II

Code Info Lot #: BS392004A, Exp: 09/2014

Product Distributed Qty 18,721 bottles

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.

Event Detail

Event Id 65780

Product Type Drugs

Status Ongoing

Recalling Firm

Torrent Pharma Inc

City Kalamazoo
State MI
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-07-22

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide