FDA recall D-1227-2014

Novartis Pharmaceuticals Corp. · Class III · 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

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

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2014-03-03
Report date: 2014-04-16
Termination date: 2014-12-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Suffern, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1227-2014