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Recall Observatory FDA recall evidence

Drug product

Ritalin HCl (methylphenidate HCl) USP, 20 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 0078-0441-05

D-1228-2014

March 03, 2014

Class III

Product summary

Firm
Novartis Pharmaceuticals Corp.
Event
Event 67633
Status
Terminated
Classification
Class III
Quantity
10,781 bottles
Official record key
drug-enforcement:D-1228-2014

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 #: F0131

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing