D-1609-2014 Class III Terminated
FDA drug recall D-1609-2014 was initiated by Apotex Corp. on Apr 18, 2014 and is designated Class III. Reason for recall: Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point. The recall status is terminated (terminated Apr 7, 2017). Affected quantity: 5,397 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 1, 2014
- Initiation Date
- Apr 18, 2014
- Termination Date
- Apr 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,397 bottles
Product Description
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.
Distribution Pattern
Nationwide.
Code Information
Lot # KM4951; Exp. 04/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1609-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026