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

FDA recall notice · announced October 1, 2014 · Apotex

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Reason for recall

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

Notes

Distribution: Nationwide.
Lot/code information: Lot # KM4951; Exp. 04/15
Quantity: 5,397 bottles
Status: Terminated
Products in this recall event:
- 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 # 60505-3 (D-1609-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.