Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)

FDA recall notice · announced December 5, 2012 · Samantha Lynn

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)

Reason for recall

Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug.

Notes

Distribution: Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan
Lot/code information: all lots within expiry through 2016
Quantity: 25,888 Boxes
Status: Terminated
Products in this recall event:
- Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish) (D-063-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.