Drug product
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
D-0608-2026
Product summary
- Firm
- Sandoz Inc
- Event
- Event 99121
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 7,803 bottles
- Official record key
drug-enforcement:D-0608-2026
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date
Code information: Lot VA0099422; Exp. Date June 30, 2028
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing