Teva’s Adderall 30 mg Tablets: Counterfeit Product - Contains Wrong Active Ingredients
[Posted 05/30/2012]
AUDIENCE: Consumer, Health Professional
ISSUE: FDA is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet. FDA’s preliminary laboratory tests revealed that the counterfeit version of Teva’s Adderall 30 mg tablets contained the wrong active ingredients. Adderall contains four active ingredients – dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. Instead of these active ingredients, the counterfeit product contained tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain.
BACKGROUND: Adderall, which is approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, is a prescription drug classified as a controlled substance – a class of drugs for which special controls are required for dispensing by pharmacists. The counterfeit Adderall tablets are round, white and do not have any type of markings, such as letters or numbers. 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.
See the Press Release for pictures of the product.
RECOMMENDATION: Anyone who believes they have the counterfeit version of Teva’s Adderall 30 mg tablets should not take or should stop taking the product. Consumers should talk to their health care professional about their condition and options for treatment.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products 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 form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[05/29/2012 – Press Release - FDA]
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