Drug recall
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch…
FDA recall event 67718 · Class II · Noven Pharmaceuticals, Inc.
Key facts
| Event ID | 67718 |
|---|---|
| Recall numbers | D-1171-2014, D-1172-2014 |
| Recalling firm | Noven Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics…, Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patches per box, Rx Only.Manufactured for Noven Therapeutics, LLC… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior… |
| Initiation date | Feb 13, 2014 |
| Report date | Mar 26, 2014 |
| Termination date | Mar 19, 2019 |
| City | Miami |
| State | FL |
| Country | United States |
| FEI number | 1000222037 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: