Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Dissolution Specification: Low dissolution outside of specifications
Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Reason Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Reason Presence of Foreign Substance: Metal embedded in a tablet.
Reason Defective Delivery System: Out of specification for shear.
Reason Defective Delivery System: Out of specification for shear.
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