Drug product
Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
D-0972-2016
Product summary
- Firm
- Novacare, LLC
- Event
- Event 71989
- Status
- Terminated
- Classification
- Class I
- Quantity
- N/A
- Official record key
drug-enforcement:D-0972-2016
Official wording
Reason: Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Code information: UPC 859613638496
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.