Drug product
Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901, Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0440-05
D-1227-2014
Product summary
- Event
- Event 67633
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10,930 Bottles
- Official record key
drug-enforcement:D-1227-2014
Official wording
Reason: Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
Code information: Lot #: F0126
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing