FDAClass IIIOctober 1, 2014

Olanzapine Orally Disintegrating Tablets 5 mg recall: Subpotent

Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for…

Why was Olanzapine Orally Disintegrating Tablets 5 mg recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # KM4951; Exp. 04/15

Product
Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for…
Recalling firm
Apotex Corp.
Quantity
5,397 bottles
Distribution
Nationwide.
Recall date
October 1, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls