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

FDA recall notice · announced April 16, 2014 · Novartis Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: F0126
Quantity: 10,930 Bottles
Status: Terminated
Products in this recall event:
- 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 Jers (D-1228-2014)
- 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 Jer (D-1227-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.