The Recall Desk
SevereFDA (Drugs)·D-063-2013·Announced 2012-12-05

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.

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 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
Category
Drug — Prescription/OTC Medication
Hazard
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.

Related recalls

Same hazard · undeclared ingredients

See all →