PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 7, 2013 Initiated: July 22, 2013 #D-830-2013

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

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.

Details

Recalling Firm
Torrent Pharma Inc
Units Affected
18,721 bottles
Distribution
Nationwide
Location
Kalamazoo, MI

Frequently Asked Questions

What product was recalled?
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. Recalled by Torrent Pharma Inc. Units affected: 18,721 bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 7, 2013. Severity: Moderate. Recall number: D-830-2013.