Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Incorrect or Missing Lot and/or Exp Date
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31
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 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.
Reason Defective Delivery System: Out of specification for shear.
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