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UPDATED: Novartis recalls some Ritalin over packaging issue

Medication guide mix-up leads it to recall over 20,000 bottles
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Novartis' Sandoz unit is voluntarily recalling nearly 22,000 bottles of Ritalin.--Courtesy of Calvero, CC BY-SA 3.0

Attention deficit hyperactivity disorder (ADHD) drugs like Ritalin have been on the FDA shortage list for a variety of reasons. Now add to that packaging problems which have led Novartis ($NVS) to recall nearly 22,000 bottles.

Novartis is voluntarily recalling one lot of 10-mg tablets and one lot of 20-mg tablets, according to an FDA Enforcement Report posting. The drugmaker recalled the products because the medication guides attached to the package inserts were printed with information related to its sustained-release product instead. The company said that while both products use the same active ingredient, methylphenidate, their medication guides are different because they contain different excipients.

In an emailed statement, the company said: "Novartis conducted an extensive medical safety assessment, which was shared with the FDA. The assessment concluded that there is no immediate significant safety risk as a result of the printing error."

Methylphenidate hydrochloride is currently on the FDA drug shortage list. Novartis' generic unit, Sandoz, lists its 5-mg , 10-mg and 20-mg tablets, on backorder until mid-April because of API availability. Its 20-mg sustained-release tablets went on backorder this week. According to other updates on that list, methylphenidate is available from other generics makers, including Mallinckrodt ($MNK), UCB and Actavis ($ACT).

Shortages of drugs like Ritalin and Adderall have vexed parents of children with ADHD. They have sometimes blamed the U.S. Drug Enforcement Agency (DEA) because the drugs are listed as controlled substances and so the DEA dictates each year how much can be produced. Adderall is not currently in short supply, but when it was in 2012, some consumers began looking to the Internet for products, which has problems of its own. Authorities discovered that year that some of the Adderall consumers bought from online pharmacy sites was counterfeit. Instead of the genuine active ingredients, the fakes contained painkillers, including the potentially habit-forming tramadol.

- the recall notices are here and here
- the drug shortage update is here

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