D-1080-2015 Class III Terminated
FDA drug recall D-1080-2015 was initiated by Apotex Inc. on Apr 7, 2015 and is designated Class III. Reason for recall: Subpotent drug The recall status is terminated (terminated Apr 7, 2017). Affected quantity: 6,467 bottles/ blister cartons.
Recall details
- Product Type
- Drugs
- Report Date
- May 20, 2015
- Initiation Date
- Apr 7, 2015
- Termination Date
- Apr 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,467 bottles/ blister cartons
Product description
Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
Reason for recall
Subpotent drug
Distribution pattern
Nationwide
Code information
Lot #: a) KY2389, Exp 05/16; b) KY2388, Exp 05/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1080-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026