FDA Recalls Unapproved Tiger King Tablets Containing Sildenafil
A&H Focal Inc. is recalling Tiger King tablets because they contain sildenafil, an unapproved drug for erectile dysfunction, and lack FDA approval.
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 agency classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the presence of an unapproved active pharmaceutical ingredient.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Tiger King tablets manufactured by A&H Focal Inc. The recall is due to the presence of sildenafil, a drug approved by the FDA for the treatment of erectile dysfunction. Because these tablets were marketed without an approved 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 identified as "Asian Food Markets." The recall covers all lots of the product. The FDA analysis determined that the inclusion of sildenafil in these tablets makes them subject to recall as unapproved pharmaceuticals.
Consumers who have purchased Tiger King tablets should stop using them immediately. The source text does not provide specific instructions for disposal or return, but consumers should generally follow guidance from the recalling firm or the FDA regarding the safe handling of recalled medications.
The recalled product
- Product
- Tiger King tablets, labeling is in foreign language
- Manufacturer
- A&H Focal Inc.
- Category
- Drug — Unapproved Pharmaceutical
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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