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Recall Observatory FDA recall evidence

Drug product

A1 Slim, Dietary Supplement Beautifully Slim, capsule, 350 mg, 30-count bottle, A1 Slim LLC Pearland TX 77584, www.A1SLIM.COM, info@a1slim.com Bar-Code A105212014

D-0058-2018

October 06, 2017

Class II

Product summary

Firm
Kiriko, LLC.
Event
Event 78235
Status
Terminated
Classification
Class II
Quantity
700 bottles
Official record key
drug-enforcement:D-0058-2018

Official wording

Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.

Code information: All lots remaining within expiry.

Distribution pattern: Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.