Home / Recalls / Novartis Pharmaceuticals Corp. / D-1227-2014

D-1227-2014 Class III Terminated

Recalled by Novartis Pharmaceuticals Corp. — Suffern, NY

Recall Details

Product Type
Drugs
Report Date
April 16, 2014
Initiation Date
March 3, 2014
Termination Date
December 2, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,930 Bottles

Product Description

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 Pattern

Nationwide and Puerto Rico

Code Information

Lot #: F0126

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