FDA Recalls Unapproved Clalis Capsules Containing Sildenafil
A&H Focal Inc. is recalling Clalis 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 per the rubric.
Plain-English summary
A&H Focal Inc. is recalling Clalis capsules, 50mg, 6-count bottles. The product labeling is in a foreign language. 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 these specific capsules have not been established by the FDA.
The product was 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 a healthcare provider for guidance.
The recalled product
- Product
- Clalis 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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