African Black Ant supplement recalled for undeclared sildenafil
Nova Products, Inc. is voluntarily recalling African Black Ant capsules because FDA testing found undeclared sildenafil, an active ingredient in erectile dysfunction drugs.
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 minimum severity score of 5 according to the rubric.
Plain-English summary
Nova Products, Inc. of Aston, Pennsylvania, is voluntarily recalling African Black Ant, 2800 mg, 6 capsules per box. The product was produced by Qinghan Hongwei Bioengineering Company in Xining City.
The recall was initiated because FDA laboratory analysis determined that the capsules contain undeclared amounts of sildenafil. Sildenafil is an active ingredient in FDA-approved drugs used to treat erectile dysfunction. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The product was distributed nationwide to retailers and distributors. Consumers should stop using the product and return it to the place of purchase or contact the recalling firm for instructions.
The recalled product
- Product
- AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City.
- Manufacturer
- Nova Products, Inc.
- Category
- Drug — Dietary Supplement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 2006-000926
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Nova Products, Inc. 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 8 products in this recall →Related recalls
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Similar recalls
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