Protect Your Health

Reporting Drug Quality Problems

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Fill out forms completely. It's important to fill the MedWatch form out completely as possible with regard to suspect product information and contact information. In 2008, the DQRS staff received 6,263 reports, but was not able to conduct adequate follow-up on one-third of those reports due to a lack of information. In many of those cases, the manufacturer’s name or the National Drug Code (NDC) number listed on the product label was missing.

Drug products are identified and reported using the NDC number. It is a unique 11-digit, 3-segment number assigned to each medication.  The number identifies the labeler or vendor, product, and trade package size. In other cases, contact information such as the phone number or email address was listed incorrectly or was not provided.

How to Report

Consumers or health care professionals can use any of these methods to report problems:

• Online - Use FDA Form 3500 at FDA's MedWatch Web page. FDA encourages online reporting because it is the quickest and most direct route.
• Mail - Download the pre-addressed, postage-paid FDA Form 3500 or call 1-800-FDA-1088 to request the form.
• Fax - Get the form (as above) and fax it to 1-800-FDA-0178.
• Phone - Call 1-800-FDA-1088.

For more information about topics for your health, visit the FDA Consumer Information Center (http://www.fda.gov/ForConsumers/default.htm).  

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