Samantha Lynn Recalls Reumofan Plus Tablets for Undeclared Ingredients
Samantha Lynn, Inc. is recalling Reumofan Plus Tablets because they contain undeclared drug ingredients, making them unapproved drugs.
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 according to the rubric.
Plain-English summary
Samantha Lynn, Inc. is recalling Reumofan Plus Tablets, 30-count bottles, because the product contains undeclared drug ingredients. This makes the product an unapproved drug that was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The recall involves 25,888 boxes of the product. The affected lots are those with expiry dates through 2016. The product was distributed nationwide in the United States as well as in Canada, Australia, Germany, Brazil, Austria, the United Kingdom, India, Chile, Switzerland, Thailand, and Japan. The remaining label information on the product is in Spanish.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on appropriate alternatives. The recall is being conducted by Samantha Lynn, Inc.
The recalled product
- Product
- Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
- Manufacturer
- Samantha Lynn, Inc
- Affected units
- 25,888
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 within expiry through 2016
Distribution
Distributed nationwide across the United States.
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