Drug product
Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
D-1081-2015
Product summary
- Firm
- Apotex Inc.
- Event
- Event 71046
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,352 bottles
- Official record key
drug-enforcement:D-1081-2015
Official wording
Reason: Subpotent drug
Code information: Lot # KL0664, Exp 04/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent