D-0970-2016 Class I Terminated
FDA drug recall D-0970-2016 was initiated by Novacare, LLC on August 24, 2015 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. The recall status is terminated (terminated August 30, 2017). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- June 15, 2016
- Initiation Date
- August 24, 2015
- Termination Date
- August 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Distribution Pattern
Nationwide
Code Information
UPC 859613274229