Focalin XR 5mg capsules carry incorrect or missing lot and expiry
Focalin XR 5 mg extended-release capsules are being recalled over a labeling issue: incorrect or missing lot number and/or expiry date. 7,803 bottles are affected.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA graded this Class III and the defect is a missing or incorrect lot and expiry marking, a documentation issue, which the rubric places at Low.
Plain-English summary
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, prescription only, manufactured by Societal CDMO Gainesville, LLC of Gainesville, Georgia, NDC 66758-235-31, is being recalled. The action covers 7,803 bottles.
The stated reason is a labeling issue: incorrect or missing lot and/or expiry date. The FDA classified the action as Class III, its least serious classification, which is applied where use of the product is not likely to cause adverse health consequences.
The affected lot is VA0099422, expiring June 30, 2028. Distribution was USA nationwide.
Patients should not stop taking a prescribed medicine without advice. Anyone holding the affected lot should speak to their pharmacist or prescriber and follow the instructions issued by the firm.
The recalled product
- Product
- FOCALIN (DEXMETHYLPHENIDATE HYDROCHLORIDE)
- Brand
- FOCALIN
- Manufacturer
- Sandoz Inc
- Category
- Drug — Extended-release capsule
- Affected units
- 7,803
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot VA0099422
- Exp. Date June 30
- 2028
Distribution
Distributed nationwide across the United States.
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