Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot #: BS392004A, Exp: 09/2014
Why it was 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.
Recalling firm
- Firm
- Torrent Pharma Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5380 Holiday Ter Ste 40, N/A, Kalamazoo, Michigan 49009-2128
Distribution
- Quantity
- 18,721 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-07-22
- FDA classified
- 2013-08-01
- Posted by FDA
- 2013-08-07
- Terminated
- 2014-01-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-830-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.