D-1435-2016 Class III Terminated
FDA drug recall D-1435-2016 was initiated by Apotex Scientific, Inc on January 26, 2016 and is designated Class III. Reason for recall: Failed Dissolution Specification: Out of specification dissolution results when testing product stability. The recall status is terminated (terminated June 15, 2022). Affected quantity: 107,880 (60 ct bottle).
Recall Details
- Product Type
- Drugs
- Report Date
- July 20, 2016
- Initiation Date
- January 26, 2016
- Termination Date
- June 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 107,880 (60 ct bottle)
Product Description
Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;
Reason for Recall
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Distribution Pattern
Nationwide, Alaska, Hawaii, and Puerto Rico.
Code Information
Lot #: KV9795, KV9794, KV9796, KX6278; Exp 04/30/2016.