Unapproved Sildenafil Supplements Recalled by FDA for Lack of Safety Data
A&H Focal Inc. is recalling LIEN CHAN FOR SEVEN DAYS capsules 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 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 LIEN CHAN FOR SEVEN DAYS capsules. The product was distributed in New York and New Jersey through six retail stores named "Asian Food Markets." The recall covers all lots of the product.
The FDA determined that the capsules contain sildenafil, a drug approved for the treatment of erectile dysfunction. Because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), it is considered an unapproved drug. The safety and efficacy of this specific product have not been established by the FDA.
Consumers who purchased these capsules should stop using them and return them to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language
- Manufacturer
- A&H Focal Inc.
- Category
- Drug — Unapproved 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)
- 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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