Wednesday, April 16, 2014
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FDA warns consumers about fake versions of Teva's Adderall

Counterfeit versions of Teva's 30 mg version of Adderall are being peddled on the Internet, so the FDA issued a warning to consumers and health-care professionals.

FDA warns consumers about fake versions of Teva's Adderall

The U.S. Food and Drug Administration said Tuesday evening that consumers and health care professionals should be wary of counterfeit versions of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that are being sold on the Internet.

Brand-name Adderall is made by Shire Pharmaceuticals and is approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, but Teva and other companies make generic versions approved by the FDA. The prescription drug is classified as a controlled substance, meaning pharmacists are supposed to keep closer track of how and when they dispense the drug.

The FDA said its preliminary lab tests revealed that the counterfeit version of Teva’s Adderall 30 mg tablets contained the wrong active ingredients. The correct version of Adderall contains four active ingredients – dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. The FDA said the fake versions, instead of these active ingredients, contained tramadol and acetaminophen, which are ingredients to treat acute pain.

Adderall is currently on the FDA’s drug shortage list because of active ingredient supply issues.

The FDA said consumers should be wary of online sources.

"Rogue websites and distributors may especially target medicines in short supply for counterfeiting," the FDA statement said.

The FDA said that Teva's authentic Adderall 30 mg tablets are round, orange/peach in color, and have “ dp” embossed on one side and “30” on the other side of the tablet. Teva’s Adderall 30 mg tablets are packaged only in a 100-count bottle with the National Drug Code (NDC) 0555-0768-02 listed.

If the pills don't look like that or they come in a blister pack, they should be considered fake.

Teva spokeswoman Denise Bradley said via email that the company learned of two examples.

"Both were purchased from illegal web sites, not through legitimate distribution channels," Bradley said. "We have reported to the FDA and continue to work with them on the investigation. We were alerted by a consumer who noticed misspellings on the fake product packaging. Our product is packaged in bottles. These fake product are packaged in foil wrappers."

The FDA asked consumers who think they received a counterfeit Adderall to contact the FDA’s Office of Criminal Investigations (OCI) at 800-551-3989.

 
David Sell
About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com.

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