Food and Drug Administration (FDA) is warning consumers and health care providers about a counterfeit version of Teva Pharmaceutical Industries’ Adderall® 30 mg tablets that is being purchased on the Internet. Adderall, a drug approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, contains four active ingredients – dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. FDA’s preliminary laboratory tests revealed that, instead of these active ingredients, the counterfeit product contained tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain.
FDA alerts consumers that authentic Adderall 30 mg tablets produced by Teva are round, orange/peach, and scored tablets with “dp” embossed on one side and “30” on the other side of the tablet. Further, Teva’s Adderall 30 mg tablets are packaged only in a 100-count bottle with the National Drug Code (NDC) 0555-0768-02 listed. The counterfeit Adderall tablets are round, white, and do not have any type of markings, such as letters or numbers. Images of the counterfeit product are included in the FDA news release, and FDA indicates that the counterfeits should be considered as unsafe, ineffective, and potentially harmful. Use of blister packaging and misspellings on product packaging (“NDS” instead of “NDC,” “Aspartrte” instead of “Aspartate,” “Singel” instead of “Single”) are additional signs that the product may be a counterfeit version of Teva’s Adderall 30 mg tablets.
FDA advises that anyone who believes they have the counterfeit version should not take or should stop taking the product, and should talk to their health care provider about their condition and options for treatment. In addition, reports of counterfeit Adderall may be submitted to FDA’s Office of Criminal Investigations (OCI) by calling 800/551-3989 or by completing the online form on the OCI Web page. Adverse events or side effects from the suspect counterfeit Adderall can be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by calling 800/332-1088 or completing the online form.
Finally, FDA advises that consumers should be extra cautious when buying their medicines from online sources. FDA notes that “rogue websites and distributors may especially target medicines in short supply for counterfeiting” and that Adderall is currently on the drug shortage list. Teva continues to release product as it becomes available, indicates FDA. When buying medicine online, FDA recommends ensuring that the Internet pharmacy is VIPPS® (Verified Internet Pharmacy Practice SitesCM) accredited.