Status
Terminated
Drug Enforcement 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.
Classification
Class II
Report Date
August 7, 2013
Termination Date
January 31, 2014
Product Information
- 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
- Product quantity
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Torrent Pharma Inc
- Address
-
5380 Holiday Ter Ste 40, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-830-2013
- Event ID
- 65780
- Recall initiation date
- July 22, 2013
- Center classification date
- August 1, 2013
- Code info
- Lot #: BS392004A, Exp: 09/2014
- More code info
- —