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Recall Observatory FDA recall evidence

Drug product

P-BOOST 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-1345-2014

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-1345-2014

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 P-Boost are: 1ct - 862545101013 5ct - 862545101051 10ct - 862545101105 20ct - 862545101204 40ct - 862545101402

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.