FDA recall D-830-2013

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

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-07-22

Report date

2013-08-07

Termination date

2014-01-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kalamazoo, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-830-2013