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.
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
Lot numbers, UPCs & expiration codes
Lot #: BS392004A, Exp: 09/2014
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-830-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 22, 2013
- FDA report date
- Aug 7, 2013
- Quantity
- 18,721 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Torrent Pharma Inc
Original FDA data
Every field from FDA enforcement report D-830-2013, exactly as published.
Show all FDA fields
- City
- Kalamazoo
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 65780
- Address
- 5380 Holiday Ter Ste 40
- Code information
- Lot #: BS392004A, Exp: 09/2014
- Postal code
- 49009-2128
- Report date
- Aug 7, 2013
- Product type
- Drugs
- Recall number
- D-830-2013
- Classification
- Class II
- Recalling firm
- Torrent Pharma Inc
- Product quantity
- 18,721 bottles
- Termination date
- Jan 31, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 22, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 1, 2013