Methylphenidate HCl Chewable Tablets, 5 mg
February 10, 2005 08:30

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

[UPDATE 02/10/2005] Recall expanded to include all lots of the product. The nationwide recall now includes all 2.5 mg, 5 mg and 10 mg dosage strengths because some tablets may contain too much or too little active ingredient.

[01/19/2005] FDA and Alliant Pharmaceuticals notified healthcare professionals and consumers of the voluntary recall of one lot of Methylphenidate HCl Chewable Tablets, 5 mg strength,indicated for Attention Deficit Hyperactivity Disorder and Narcolepsy. After testing and evaluation, Alliant found that lot number #AMT50402A [expiration date April 2006] 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.

Read the complete MedWatch 2005 Safety Summary, including links to both firm press releases, at:

http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Methylin

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