FDA-Drug2014-10-01Class III

Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03

Apotex Corp.
Hazard

Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.

Sold states
Nationwide.
Affected count
5,397 bottles
Manufactured in
2400 N Commerce Pkwy Ste 400, N/A, Weston, FL, United States
Products
Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1609-2014

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