FDA Recalls Unapproved Gold Vigra Capsules Containing Sildenafil
A&H Focal Inc. is recalling Gold Vigra capsules because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
The U.S. Food and Drug Administration (FDA) is recalling Gold Vigra capsules, 50mg, 6-count bottles, manufactured by A&H Focal Inc. The product labeling is in a foreign language. The recall is classified as Class I.
The FDA determined that these products contain sildenafil, a drug approved by the FDA for the treatment of erectile dysfunction. Because the Gold Vigra capsules were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), they are considered unapproved drugs. Consequently, their safety and efficacy have not been established.
The affected products were distributed in New York and New Jersey through six retail stores named "Asian Food Markets." All lots are subject to the recall. Consumers should stop using the product and return it to the place of purchase.
The recalled product
- Product
- GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language
- Manufacturer
- A&H Focal Inc.
- Category
- Drug — Unapproved Drug
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)
- All Lots
Distribution
Part of a larger recall action
This product is one of 21 recalled by A&H Focal 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.
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