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Recall Observatory FDA recall evidence

Drug 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

D-830-2013

July 22, 2013

Class II

Product summary

Firm
Torrent Pharma Inc
Event
Event 65780
Status
Terminated
Classification
Class II
Quantity
18,721 bottles
Official record key
drug-enforcement:D-830-2013

Official wording

Reason: 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.

Code information: Lot #: BS392004A, Exp: 09/2014

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.