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.
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