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Recall Observatory FDA recall evidence

Drug product

NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466

D-1346-2014

November 19, 2013

Class I

Product summary

Firm
Tendex
Event
Event 66897
Status
Terminated
Classification
Class I
Quantity
unknown
Official record key
drug-enforcement:D-1346-2014

Official wording

Reason: Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.

Code information: Lot # F51Q. EXP: 07/16 The UPC Codes for Naturect are: 1ct- 893020242013 5ct - 893020242051 10ct - 893020242105 20ct - 893020242204 40ct - 893020242402

Distribution pattern: Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.