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Non-safety-related voluntary recall of a limited portion of Daytrana(R) (methylphenidate transdermal system) patches announced
Date:12/3/2009

Expiry -------- ----- ------------ ------------------- ---------- 20 mg 30 54092-554-30 33988, 34174, 34175 12/31/2010 30 mg 30 54092-555-30 33990, 34179 12/31/2010 Voluntary Market Withdrawal Strength Count NDC# Lot Number(s) Expiry -------- ----- ------------ ------------- ---------- 30 mg 30 54092-555-30 33991 12/31/2010

Important Safety Information

Daytrana is indicated for the treatment of ADHD in children aged 6 to 12 years.

Tell your doctor about any heart conditions, including structural abnormalities, your child or a family member may have. Inform your doctor immediately if the child develops symptoms that suggest heart problems, such as chest pain or fainting.

Daytrana should not be used if the child has: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients of Daytrana; glaucoma; discontinued in the last 14 days or is taking a monoamine oxidase inhibitor (MAOI); tics, or family history or diagnosis of Tourette's syndrome.

Tell your doctor before using Daytrana if the child: is being treated for or has symptoms of depression (e.g. sadness, worthlessness, or hopelessness) or bipolar disorder; has family history of tics; has abnormal thoughts or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell your doctor immediately if the child develops any of these conditions/symptoms while using Daytrana.

In clinical studies, side effects were generally mild to moderate. The most common side effects reported with Daytrana were decreased appetite, sleeplessness, sadness/crying, twitching, weight loss, nausea, vomiting, tics, and affect lability (mood swings).
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SOURCE Shire plc
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