Abbott is warning consumers and health care providers about counterfeit Vicodin ES® purchased via the Internet. Abbott reports that the counterfeit product drug and package do not match that of Abbott’s Food and Drug Administration (FDA)-approved Vicodin ES (hydrocodone bitartrate and acetaminophen). <!--more-->The counterfeit product is packaged in a 10-tablet blister with a fake Vicodin ES label that contains misspellings and no Abbott logo. The counterfeit tablets are off-white with the markings F and P embossed on one side of the tablet. Labeling for Fenak Plus® was found underneath the counterfeit Vicodin ES label. Abbott notes that Fenak Plus contains a different active ingredient (diclofenac) than Vicodin ES and is used to treat pain and fever. Vicodin ES is a pain relief medication sold in the United States through secure drug supply channels to reach consumers. Authentic Vicodin ES is white and is embossed with Vicodin ES. Abbott Vicodin ES is packaged in a 25 tablet blister package and four blister packages are packaged together (100 count) and intended for hospital use. Also, each individual blister has detailed information and a bar code. Images of the counterfeit product and authentic Vicodin ES are shown in a consumer alert posted on the Abbott Web site.
Abbott advises that anyone who has the counterfeit version should stop taking the product. Further, consumers who suspect a product to be counterfeit or have questions about the legitimacy of Vicodin ES are encouraged to make a report to FDA’s Office of Criminal Investigations (OCI) by calling 800/551-3989 or by visiting the OCI Web site. Anyone experiencing any adverse events or side effects related to the use of this counterfeit product can also make a report to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by completing the online form on the FDA Web site or by calling 800/332-1088 to request a form by mail.