Drug product

JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle

D-1249-2014

May 20, 2013

Class I

Product summary

Firm: Dolphin Intertrade Corporation
Event: Event 65383
Status: Terminated
Classification: Class I
Quantity: 998 boxes
Official record key: drug-enforcement:D-1249-2014

Official wording

Reason: Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.

Code information: Manufacturing Codes: 10.06.2011 Exp. 09.06.2013

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.