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
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
Lot numbers, UPCs & expiration codes
Lot #: F0126
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1227-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 3, 2014
- FDA report date
- Apr 16, 2014
- Quantity
- 10,930 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Pharmaceuticals Corp.
Original FDA data
Every field from FDA enforcement report D-1227-2014, exactly as published.
Show all FDA fields
- City
- Suffern
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 67633
- Address
- 25 Old Mill Rd
- Code information
- Lot #: F0126
- Postal code
- 10901-4106
- Report date
- Apr 16, 2014
- Product type
- Drugs
- Recall number
- D-1227-2014
- Classification
- Class III
- Recalling firm
- Novartis Pharmaceuticals Corp.
- Product quantity
- 10,930 Bottles
- Termination date
- Dec 2, 2014
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 3, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 8, 2014