Memantine Hydrochloride Extended-Release Capsules Recalled for Dissolution Failure
The Harvard Drug Group is recalling 246 cartons of Memantine Hydrochloride Extended-Release Capsules, 28mg, due to failed dissolution specifications observed during stability studies.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which indicates the product is unlikely to cause adverse health consequences. The issue is a quality control failure (dissolution) without reported injuries or illnesses.
Plain-English summary
The Harvard Drug Group is recalling 246 cartons of Memantine Hydrochloride Extended-Release Capsules, 28mg. The product is packaged in 100-count Unit Dose Cartons and is available by prescription only. The specific lot number is M02465D, and the NDC is 0904-6735-61. The product was manufactured for Lupin Pharmaceuticals, Inc., and distributed by Major Pharmaceuticals.
The recall was initiated because a high out-of-specification result was observed during stability studies regarding the product's dissolution. Dissolution is a critical quality attribute that ensures the drug releases its active ingredient at the intended rate and amount. A failure in this specification may result in the medication not working as intended.
The affected product was distributed nationwide in the United States. Patients and healthcare providers should discontinue use of the recalled lot and contact their pharmacist or healthcare provider for a replacement or alternative treatment. No adverse health events or illnesses have been reported in connection with this recall.
The recalled product
- Product
- MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
- Brand
- MEMANTINE HYDROCHLORIDE
- Manufacturer
- The Harvard Drug Group
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 246
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 (1)
- Lot# M02465D
Distribution
Distributed nationwide across the United States.
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