Safety Alerts & Recalls

What does this mean?

This recall for Daytrana (methylphenidate) transdermal system patch was issued at a warehouse and pharmacy level only. The FDA and the manufacturer have determined that any recalled product that may have been dispensed to patients does not pose a significant health risk. All Daytrana patches can continue to be used by patients. However, patches with a release liner that cannot be removed or patches that are damaged while being opened should not be used.

If you or your child uses Daytrana (methylphenidate) transdermal system patch, 10 mg (1.1 mg/hr), 15 mg (1.6 mg/hr), 20 mg (2.2 mg/hr), and 30 mg (3.3 mg/hr) and you are having trouble opening or applying your Daytrana patches, you should speak to your pharmacist. If you have any other concerns about your medicine, you should speak to your doctor or pharmacist.

Noven Pharmaceutical Recalls Several Lots of Daytrana Patches

Noven Pharmaceutical and Shire US Inc. has recalled several lots of Daytrana (methylphenidate) transdermal system patch 10 mg (1.1 mg/hr), 15 mg (1.6 mg/hr), 20 mg (2.2 mg/hr), and 30 mg (3.3 mg/hr). The following lot numbers have been recalled because the transdermal patches in these lots may be difficult to peel open for use: Daytrana (methylphenidate) transdermal patch, 10 mg (1.1 mg/hr): Lot number 41843

Daytrana (methylphenidate) transdermal patch, 15 mg (1.6 mg/hr): Lot number 43783

Daytrana (methylphenidate) transdermal patch, 20 mg (2.2 mg/hr): Lot numbers 49203 and 50265

Daytrana (methylphenidate) transdermal patch, 30 mg (3.3 mg/hr): Lot numbers 43008 and 48591

Daytrana contains the active ingredient methylphenidate and is commonly used in the treatment of attention deficit disorders. This recall alert only applies to the select lots of Daytrana (methylphenidate) transdermal system patch 10 mg (1.1 mg/hr), 15 mg (1.6 mg/hr), 20 mg (2.2 mg/hr), and 30 mg (3.3 mg/hr). No other methylphenidate products were involved in this recall.

To view the FDA notice about this recall, please visit: more information here

Source: FDA
Publication Date: 2012-07-22
Last Updated: 2012-07-24

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