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Report Counterfeit Drugs and Suspicious Vendors

Report Counterfeit Drugs and Suspicious Vendors

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Your cooperation is an essential part of FDA’s and state regulatorsʹ efforts to protect the public from
diverted, counterfeit, and otherwise unsafe prescription drugs. You can use this guide to help health and
law enforcement officials. You can also assist by maintaining copies of unsolicited offers, pedigrees, or
other pertinent documents, as well as any suspicious products.

For Suspicious Products For Suspicious Vendors
Check risk factors for
packaging, labeling and product
Check all risk factors
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Consult pharmacy’s
reporting procedures
Consult pharmacy’s
reporting procedures
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Fill out FDA’s Form 3500
to report the product at
www.fda.gov/medwatch
Visit
www.fda.gov/oci
to report the vendor to the FDA.
Include detailed and timely information
about the incident, such as:

•Name and strength of the drug
•Lot number and expiration date
•Reasons for suspicion about the product, packaging, documentation, or offer
•Source of the prescription drug (if known)

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Notify state regulator of wholesale distributors
www.nabp.net/vawd/ATLWDs.pdf

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