Unapproved Sildenafil Tablets Recalled by FDA for Lack of Safety Data
The FDA is recalling ZHANSHENG WEIGE CHAOYUE XILISHI tablets because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
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 minimum severity score of 4 according to the rubric.
Plain-English summary
A&H Focal Inc. is recalling ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottles. The product labeling is in a foreign language. The recall covers all lots of the product.
The FDA determined that these products contain sildenafil, a drug approved for the treatment of erectile dysfunction. Because the tablets were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), they are considered unapproved drugs. The safety and efficacy of these specific products have not been established.
The product was distributed in New York and New Jersey through six retail stores named "Asian Food Markets." Consumers who have purchased these tablets should stop using them and return them to the place of purchase or contact the recalling firm for instructions.
The recalled product
- Product
- ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 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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