Novartis Recalls Dexmethylphenidate HCl Extended-Release Capsules for Dissolution Failure
Novartis Pharmaceuticals Corp. is recalling 10,767 bottles of Dexmethylphenidate HCl Extended-Release capsules because stability testing showed the product failed to meet dissolution specifications.
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: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/stability specification failure without reported injuries or illnesses.
Plain-English summary
Novartis Pharmaceuticals Corp. is recalling 10,767 bottles of Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. The product was manufactured by Alkermes Gainesville LLC for Sandoz Inc. The specific lot affected is F0002, with an expiration date of 12/2016.
The recall was initiated because the product failed to meet dissolution specifications. Specifically, an out-of-specification result (above specification) was obtained at the 6-hour dissolution time point during 12-month stability testing. This indicates the medication may not release the active ingredient at the intended rate.
The affected product was distributed to a site in New Jersey. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
- Manufacturer
- Novartis Pharmaceuticals Corp.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 10,767
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 (2)
- Lot #: F0002
- Exp 12/2016
Distribution
Distribution scope not specified by the agency.
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