Drug 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
D-1609-2014
Product summary
- Firm
- Apotex Corp.
- Event
- Event 69177
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,397 bottles
- Official record key
drug-enforcement:D-1609-2014
Official wording
Reason: Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Code information: Lot # KM4951; Exp. 04/15
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Subpotent