FDA Recalls Unapproved Power V8 Viagra Tablets Containing Sildenafil
A&H Focal Inc. is recalling Power V8 Viagra tablets because they contain sildenafil, an unapproved drug with unestablished safety and efficacy.
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 source text identifies the recall as FDA Class I. Per the rubric, FDA Class I recalls are assigned a severity score of 4 (Severe) or higher, as they represent a reasonable probability of serious adverse health consequences or death.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Power V8 Viagra tablets, 200mg, 10-Grain bottles, manufactured by A&H Focal Inc. The product labeling is in a foreign language. The recall is classified as Class I by the FDA.
The recall was initiated because FDA analysis found the products contain sildenafil, an FDA-approved drug for the treatment of erectile dysfunction. Because these specific products are not approved under a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), they are considered unapproved drugs for which 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." Consumers who possess these products should stop using them and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language
- Manufacturer
- A&H Focal Inc.
- Category
- Drug — Unapproved Medication
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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