FDA Issues Warning For Counterfeit Adderall

FDA Issues Warning For Counterfeit AdderallThe U.S. Food & Drug Administration (FDA) just issued a warning about counterfeit Adderall. The counterfeit version of Teva Pharmaceutical Industries’ Adderall tablets were purchased on the Internet and contain fake active ingredients. The bogus pills are meant to imitate Teva Adderall 30 milligram tablets.

Adderall is a prescription medication approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, and is classified as a controlled substance. Controlled substances are a class of drugs for which special controls are required for dispensing by pharmacists.

FDA’s preliminary laboratory tests revealed that the counterfeit Adderall 30 mg tablets contained the wrong active ingredients. Adderall contains four active ingredients–dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. The bogus Adderall contain, instead, tramadol and acetaminophen, ingredients in medications used to treat acute pain.

Adderall is on the agency’s drug shortage list  due to active pharmaceutical ingredient supply issues; Teva continues to release Adderall as it becomes available.

The FDA advises consumers to be extra cautious when purchasing medicines from online sources and notes that so-called “rogue” web sites and distributors may be targeting medicines in short supply for counterfeiting.

The counterfeit Adderall tablets are round, white, smooth, and have no markings, such as letters or numbers. The product is dispensed in a blister package and there are spelling errors on the package, such as “NDS” instead of “NDC,” “Aspartrte” instead of “Aspartate,” and “Singel” instead of “Single.” Counterfeit Adderall should be considered as unsafe, ineffective, and potentially harmful.

Authentic Adderall 30 mg tablets produced by Teva are round, orange/peach, and scored tablets with the letters “dp” embossed on one side of the tablet and the number “30” on the tablet’s other side. Teva’s Adderall 30 mg tablets are packaged only in a 100-count bottle with the National Drug Code (NDC) 0555-0768-02 listed.

Consumers and health care professionals are encouraged to report adverse events or side effects from the suspect counterfeit Adderall to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Complete and submit the report online: www.fda.gov/MedWatch/report.htm.; download the form at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm or call 1.800.332.1088 to request a reporting form. Complete and return the form to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

Consumers who believe they have received counterfeit Adderall should contact the FDA’s Office of Criminal Investigations (OCI) at 1800.551.3989 or click here.

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