Recalls / Class III
Class IIID-1228-2014
Product
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
- Brand name
- Ritalin
- Generic name
- Methylphenidate Hydrochloride
- Active ingredient
- Methylphenidate Hydrochloride
- Route
- Oral
- NDCs
- 0078-0439, 0078-0440, 0078-0441
- FDA application
- NDA010187
- Affected lot / code info
- Lot #: F0131
Why it was recalled
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
Recalling firm
- Firm
- Novartis Pharmaceuticals Corp.
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 25 Old Mill Rd, N/A, Suffern, New York 10901-4106
Distribution
- Quantity
- 10,781 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-03-03
- FDA classified
- 2014-04-08
- Posted by FDA
- 2014-04-16
- Terminated
- 2014-12-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1228-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.