August 2012 FDA Recall Drug by Samantha Lynn, Inc
D-063-2013 - Marketed without an approved NDA/ANDA
This Class I drug recall was voluntarily initiated by Samantha Lynn, Inc on August 27, 2012 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-063-2013
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.
08-27-2012
12-05-2012
25,888 Boxes
Recall Profile & Regulatory Data
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Samantha Lynn, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan
03-18-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
Batch or Lot Expiration Information
Lot# all lots within expiry through 2016
