FDA-Drug2013-08-07Class II
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
Torrent Pharma Inc
Hazard
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.
Sold states
Nationwide
Affected count
18,721 bottles
Manufactured in
5380 Holiday Ter Ste 40, N/A, Kalamazoo, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-830-2013Don't want to check this manually?
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