Why it was recalled
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.
Product description
Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
Lot numbers, UPCs & expiration codes
all lots within expiry through 2016
Where it was sold
Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-063-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 27, 2012
- FDA report date
- Dec 5, 2012
- Quantity
- 25,888 Boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Samantha Lynn, Inc
Original FDA data
Every field from FDA enforcement report D-063-2013, exactly as published.
Show all FDA fields
- City
- Norwalk
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 63017
- Address
- 10503 Meadow Rd
- Code information
- all lots within expiry through 2016
- Postal code
- 90650
- Report date
- Dec 5, 2012
- Product type
- Drugs
- Recall number
- D-063-2013
- Classification
- Class I
- Recalling firm
- Samantha Lynn, Inc
- Product quantity
- 25,888 Boxes
- Termination date
- Mar 18, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Reumofan Plus Tablets, 30-count bottle per Box, (remaining label information in Spanish)
- Distribution pattern
- Nationwide and Canada, Australia, Germany, Brazil, Austria, United Kingdom, India, Chile, Switzerland, Thailand, Japan
- Recall initiation date
- Aug 27, 2012
- Initial firm notification
- Press Release
- Center classification date
- Nov 23, 2012