Naturect Capsules Recalled for Undeclared Tadalafil Ingredient
Tendex is recalling Naturect Capsules because FDA analysis found the product contains undeclared tadalafil, making it an unapproved drug.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Tendex is recalling Naturect Capsules Dietary Supplement 500 mg, 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 limited to Lot # F51Q with an expiration date of 07/16.
The U.S. Food and Drug Administration (FDA) determined that the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis revealed that the capsules contain the undeclared active ingredient tadalafil. Consequently, the FDA classifies these products as unapproved drugs.
The recall is distributed nationwide. Consumers should stop using the recalled product and return it to the place of purchase for a refund or contact the recalling firm for instructions.
The recalled product
- 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
- 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
Same manufacturer · Tendex
See all →- SevereP-Boost Capsules Recalled for Undeclared Tadalafil Ingredient
FDA (Drugs) · 2014-05-28
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