Reumofan Plus Tablets…

Date

Dec. 5, 2012

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): 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)

Status

Terminated

Filed by

Samantha Lynn, Inc

Product

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

Reason

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.

Distribution pattern

Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan

Quantity

25,888 Boxes

Codes and lots

all lots within expiry through 2016

Recall started

Aug. 27, 2012

Recall number

D-063-2013

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-063-2013. The agency record governs; check it and the company before acting.