Reporting to the FDA is Important to YOU

Consumers play an important public health role by reporting to the FDA any problems when using any product that the FDA regulates. The FDA regulates human drugs, animal drugs, medical devices, biological products, foods, dietary supplements, cosmetics and radiation-emitting electronic products. Immediate reporting plays an even more important role.

There are four types of problems that should always be reported:

Serious Adverse Event - Results in death, is life threatening, causes admission to hospital or longer than expected stay, causes permanent disability, birth issues/stillbirth or requires care to prevent permanent damage.

Product Quality Problem - Suspected counterfeit product, contamination suspected due to unusual odor or color and inaccurate or unreadable product labeling.

Product Use Error - Mixing up products with similar names/packaging, wrong dose taking due to confusing instructions/label, error using a device due to confusing or misleading design/instructions/packaging or lab test used for another purpose.

Problem with Different Manufacturer of Same Medicine - Not getting same result from generic as brand name.

Here is how to report to the FDA:
For the FDA’s 24 hour emergency line, call 301-443-1240.
For human vaccine reporting, call 800-822-7967.
For blood transfusion fatalities, call 301-827-6220.
For cosmetic problems, call 800-332-1088.
To report illegal or suspicious online products, go to www.fda.gov/oc/buyonline/buyonlineform.htm
or forward emails to webcomplaints@ora.fda.gov.
For animal drug or device problems, call 1-888-332-8387.

To report all other problems, and to find the FDA Consumer Complaint Coordinator in your geographic area go to www.fda.gov/opacom/backgrounders/complain.html.

Source: FDA 101: How to Use the Consumer Complaint System and MedWatch