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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Alliant Pharmaceuticals Issues Voluntary Nationwide Recall of One Lot of Methylin CT, 5mg
Methylphenidate-based product being voluntarily recalled because of possible health risk

Contact:
Sharon Kraun
678-468-0064

FOR IMMEDIATE RELEASE -- Alpharetta, Georgia -- January 14, 2005 -- Alliant Pharmaceuticals, Inc. is voluntarily recalling one lot of Methylphenidate HCl Chewable Tablets, 5 mg strength, lot number #AMT50402A. After testing and evaluation, Alliant found that this lot of 5 mg strength might contain up to three times the active ingredient, and elected to recall the medication as it could pose serious health risk for some patients. Methylphenidate HCl Chewable Tablets (Methylin® CT) are a therapy for Attention Deficit Hyperactivity Disorder and Narcolepsy.

Alliant immediately notified the FDA of its findings, and is notifying doctors and pharmacists of the recall by letter. They will be asking pharmacists to notify patients who purchased the recalled product from their pharmacy. Distributors and pharmacies should check the lot numbers on the product label and promptly quarantine any product with the lot number #AMT50402A and expiration date of April 2006.

"We are committed to taking whatever steps are necessary to ensure the safety of all patients who use any one of our products," said Mark Pugh, President of Alliant Pharmaceuticals. "We are confident that this matter will be resolved quickly."

Of the 2,820 bottles from this lot, the company estimates fewer than 500 bottles of the affected product are in distribution. To date, the company has not received any complaints or reports of adverse events associated with the affected lot. Patients should call their pharmacists or physicians if they have questions about the recall. Health care providers or patients who have questions or wish to report adverse events can also contact Chris LaFreniere, Alliant Pharmaceuticals, at 770-817-4500.

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