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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Product Detail

Product Description 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
Recall Number D-1228-2014
Classification Class III
Code Info Lot #: F0131
Product Distributed Qty 10,781 bottles
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 the two products contain the same active ingredient, methylphenidate, the Medication Guides are not identical because the two products contain different excipients.

Event Detail

Event Id 67633
Product Type Drugs
Status Ongoing
Recalling Firm Novartis Pharmaceuticals Corp.
City Suffern
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-03
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico