Manufacturer Noven Therapeutics has issued a voluntary recall of three strengths of the Daytrana patch, a topical (used on the skin) ADHD treatment.
This is a class II recall, the most common type of recall, which means that there is a situation where use of the recalled medication may cause temporary or medically reversible adverse health consequences, but the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.
Who can recall a drug?
A manufacturer can voluntarily recall their medication, or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication. In this case, the manufacturer has voluntarily recalled four lots of Daytrana 15 mg, 20 mg, and 30 mg patches.
Why has Daytrana been recalled?
The recall was initiated because some Daytrana patches “do not meet the release liner removal specification.” This means that the liner may be more difficult than normal to remove when opening the packaging.
When was the recall initiated?
The affected lots of Daytrana were recalled by the manufacturer on December 23, 2015.
Are patients who have taken this medication being notified?
No. This is a class II recall, which means that it isn’t necessary to notify you unless your doctor believes it may have an effect on your health.
If you have concerns that your prescription may be affected, contact your doctor or your pharmacist.
Which products were affected?
In this recall, four lots and three strengths of Daytrana are affected.
Drug: Daytrana 15 mg patch
Lot: 77303, expiration 6/30/2016
National Drug Code (NDC): 68968-5553-03
Drug: Daytrana 20 mg patch
Lot: 77140, expiration 5/31/2016
National Drug Code (NDC): 68968-5554-03
Drug: Daytrana 30 mg patch
Lots: 77379 and 75059, expiration 5/31/2016
National Drug Code (NDC): 68968-5555-03