D-1347-2016 Class II Terminated
FDA drug recall D-1347-2016 was initiated by Murray International Trading Co., Inc. on April 20, 2016 and is designated Class II. Reason for recall: Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs. The recall status is terminated (terminated June 14, 2018). Affected quantity: unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- July 20, 2016
- Initiation Date
- April 20, 2016
- Termination Date
- June 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
FUCONPO CAPSULE, packaged in a 30-count bottle within a box, remaining labeling contains Chinese characters.
Reason for Recall
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
All lots