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FDAFDA · Food and drugs·Recall number D-1227-2014

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

Published April 16, 2014 · Recall initiated: March 3, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
RITALIN
Manufacturer
Novartis Pharmaceuticals Corp.
Distributor
Nationwide and Puerto Rico
UPC
0300780441056
Lot
Lot #: F0126
Risk classification
Class III
Area (FDA)
drug
Country
United States

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