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Recall Observatory FDA recall evidence

Drug product

CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005.

D-1569-2014

August 20, 2014

Class III

Product summary

Firm
ChiroNutraceutical LLC
Event
Event 69076
Status
Terminated
Classification
Class III
Quantity
12,948 Bottles
Official record key
drug-enforcement:D-1569-2014

Official wording

Reason: Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.

Code information: Lot #: 072010-22, Exp: 12/2013; Lot #: 072010-23, Exp: 01/2014; Lot #: 072010-25, Exp: 03/2014; Lot #: 072010-26, Exp: 04/2014; Lot #: 072010-27, Exp: 05/2014; Lot #: 072010-29, Exp: 07/2014; Lot #: 072010-30, Exp: 08/2014; Lot #: 072010-31, Exp: 09/2014; Lot #: 072010-33, Exp: 11/2014; Lot #: 072010-34, Exp: 01/2015; Lot #: 072010-36, Exp: 02/2015; Lot #: 072010-39, Exp: 05/2015; Lot #: 072010-43, Exp: 06/2015; and Lot #: 072010-48, Exp: 10/2015.

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.