METHYLPHENIDATE Recall D-0071-2023
Description: Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
METHYLPHENIDATE Recall D-0071-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0071-2023 |
| Event ID | 91161 |
| Brand | DAYTRANA |
| Generic Name | METHYLPHENIDATE |
| Manufacturer | METHYLPHENIDATE |
| Original Package? | 1 |
| Active Substance | METHYLPHENIDATE |
| Drug Route | TRANSDERMAL |
| Distribution | Nationwide in the USA |
| Quantity | 3977 boxes |
| Recall Reason | Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches. |
| Drug Classification | Class II |
| Drug Code Info | 20221207 |
| Product NDC | 68968-5552 68968-5553 68968-5554 |
| Product NUI | N0000175739 N0000175729 |
| Pharma Class (PE) | Central Nervous System Stimulation [PE] |
| Pharma Class (EPC) | Central Nervous System Stimulant [EPC] |
| Recall Initiation Date | 20221116 |
| Report Date | 20221207 |
| Classification Date | 20221128 |
| Address | 11960 Sw 144th St Miami, FL 33186-6109 United States |
| Recalling Firm | Noven Pharmaceuticals Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 207ZZ9QZ49 |
| Drug Application Number | NDA021514 |
| Structured Product Labeling (SPL ID) | 50fce36a-7e6e-4c46-bce9-419884b5162a |
| Structured Product Labeling (SPL Set ID) | 2c312c31-3198-4775-91ab-294e0b4b9e7f |
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