D-1228-2014 Class III Terminated
FDA drug recall D-1228-2014 was initiated by Novartis Pharmaceuticals Corp. on Mar 3, 2014 and is designated Class III. 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… The recall status is terminated (terminated Dec 2, 2014). Affected quantity: 10,781 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 16, 2014
- Initiation Date
- Mar 3, 2014
- Termination Date
- Dec 2, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,781 bottles
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
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 #: F0131
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1228-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026