FDA Recalls Unapproved Hard Ten Days Capsules Containing Sildenafil
A&H Focal Inc. is recalling Hard Ten Days capsules because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 recall is classified as FDA Class II, which corresponds to the 'Severe' severity level in the rubric, particularly given the presence of an unapproved active pharmaceutical ingredient.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Hard Ten Days capsules, 4500mg, 6-count bottles, manufactured by A&H Focal Inc. The product labeling is in a foreign language. The recall is classified as Class II.
The FDA determined that these products contain sildenafil, a drug approved by the FDA 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.
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 who possess this product should stop using it and contact the recalling firm or a healthcare professional for further instructions.
The recalled product
- Product
- HARD TEN DAYS capsules, 4500mg, 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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