FDA (Drugs) recall action 67633
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Novartis is recalling Ritalin tablets because the attached Medication Guide contained information for the sustained-release version. The recall is limited to a specific lot distributed nationwide and in Puerto Rico.
Novartis is recalling 10,781 bottles of Ritalin 20 mg tablets because the attached Medication Guide contained information for Ritalin SR instead of Ritalin Tablets.