Germany Niubian tablets recalled for containing unapproved sildenafil
A&H Focal Inc. is recalling Germany Niubian tablets because FDA analysis found 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 Germany Niubian tablets, 3000mg, 10-count bottles. The product labeling is in a foreign language. The recall covers all lots of the product.
The FDA initiated this recall because analysis found the tablets 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 for which safety and efficacy 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 this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- GERMANY NIUBIAN tablets, 3000mg, 10-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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