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Recall Observatory FDA recall evidence

Drug product

B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040.

D-0424-2015

December 19, 2014

Class II

Product summary

Firm
Bethel Nutritional Consulting, Inc
Event
Event 70096
Status
Terminated
Classification
Class II
Quantity
UNKNOWN
Official record key
drug-enforcement:D-0424-2015

Official wording

Reason: Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss

Code information: Lot #: 20213, Exp 12/22/2016.

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss