P-Boost Capsules Recalled for Undeclared Tadalafil Ingredient
Tendex is recalling P-Boost Capsules because FDA analysis found the product contains undeclared tadalafil, making it an unapproved drug.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Tendex is recalling P-Boost Capsules Dietary Supplement 500 mg, which are distributed by P-Boost in Los Angeles, California. The product is supplied in 1-count blister packs and 5, 10, 20, and 40-count bottles. The recall is nationwide.
The U.S. Food and Drug Administration (FDA) initiated this recall because analysis found the product contains the undeclared active ingredient tadalafil. The presence of this ingredient means the product is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), effectively making it an unapproved drug rather than a dietary supplement.
Consumers who have purchased P-Boost Capsules should stop using the product and contact the distributor or manufacturer for instructions on how to return it. The specific lot number is F51Q with an expiration date of 07/16.
The recalled product
- 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
- Manufacturer
- Tendex
- Category
- Drug — Dietary Supplement
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Tendex under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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See all →- CriticalNaturect Capsules Recalled for Undeclared Tadalafil Ingredient
FDA (Drugs) · 2014-05-28
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