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Class I: serious health riskTerminated

Pain Free By Nature REUMOFAN PLUS Tablets Recall

REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC

Pain Free By Nature · Harper, KS

Risk level
Class I
Reported by FDA
May 21, 2014
Recall ID
D-1322-2014
Check your lot numberHow we source this data

Summary

Pain Free By Nature recalled REUMOFAN PLUS Tablets starting Mar 13, 2014. The FDA classified it as Class I (serious health risk) and published enforcement report D-1322-2014 on May 21, 2014. Reason: Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol. Status: Terminated.

Why it was recalled

Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.

Product description

REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.

Lot numbers, UPCs & expiration codes

All lots

Where it was sold

Nationwide including Puerto Rico

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-1322-2014
Classification
Class I
Status
Terminated
Recall initiated
Mar 13, 2014
FDA report date
May 21, 2014
Quantity
7,123 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Pain Free By Nature

Original FDA data

Every field from FDA enforcement report D-1322-2014, exactly as published.

Show all FDA fields
City
Harper
State
KS
Status
Terminated
Country
United States
Event ID
67726
Address
1504 Washington St
Code information
All lots
Postal code
67058-1554
Report date
May 21, 2014
Product type
Drugs
Recall number
D-1322-2014
Classification
Class I
Recalling firm
Pain Free By Nature
Product quantity
7,123 bottles
Termination date
Jun 1, 2015
Reason for recall
Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.
Voluntary / mandated
Voluntary: Firm initiated
Product description
REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.
Distribution pattern
Nationwide including Puerto Rico
Recall initiation date
Mar 13, 2014
Initial firm notification
Press Release
Center classification date
May 15, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1322-2014, published May 21, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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