Safety Alerts & Recalls
What does this mean?
This voluntary recall is not due to product safety issues. All Daytrana patches, including those in the lots listed in this alert, can continue to be used. However, patches with a release liner that cannot be removed or patches that are damaged while being opened should not be used.
If you are or someone you care for is using Daytrana and you are concerned, please follow up with your doctor or pharmacist. You can also call Shire's Daytrana Customer Service at 1-800-828-2088, option 1, if you have any problems using the patches.
If you have any other medical questions, you should contact your doctor or other healthcare provider.
Additional List of Recalled Lots of Daytrana Patches Published By FDA
This week's FDA Enforcement Report published additional lot numbers associated with the December 2009 recall of Daytrana Pataches from Shire Pharmaceuticals. These lots are being recalled because some Daytrana patches may not meet their release liner removal specification. As a result, patients and caregivers could have difficulty removing the liners from the patches.
The complete list of lot numbers in the recall include: 1) Daytrana 10 mg - Lots 33985, 34167, 2994211, 3014711, and 3014811
2) Daytrana 15 mg - Lots 33986, 34168, 38127, and 38697
3) Daytrana 20 mg - Lots 33988, 33989, 34173, 34174, 34175, 37611, 37686, 37743, 38126, 38700, 39098, and 2819711
4) Daytrana 30 mg - Lots 33040, 33047, 33209, 33210, 33990, 33991, 33993, 33995, 34178, 34179, 34191, 37788, and 3073611
Daytrana is a patch form of methylphenidate used to treat attention deficit hyperactivity disorder (ADHD). Methylphenidate is also sold under the other names Concerta, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, and Ritalin-SR. This recall does not affect these other products.
To view the FDA notice about this recall, please visit: more information here
To view the iGuard Safety Alert about the December 2009 recall, please visit: more information here