Major Pharmaceuticals memantine extended-release capsules fail dissolution specifications
Major Pharmaceuticals is recalling one lot of Memantine Hydrochloride Extended-Release Capsules, 7 mg, after the product failed dissolution specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a failed dissolution specification, which can alter the rate of drug release and creates a risk of harm with no injuries reported.
Plain-English summary
Major Pharmaceuticals is recalling Memantine Hydrochloride Extended-Release Capsules, 7 mg, supplied as 100 capsules in 10 x 10 blister packs, NDC 0904-6734-61.
The stated reason is failed dissolution specifications. Dissolution testing measures how a capsule releases its active ingredient, and an extended-release formulation that falls outside specification may not deliver the drug at the intended rate. The FDA classified the action as Class II.
The affected lot is N02425, expiry 05/31/2027. Distribution was US nationwide.
This is a prescription medicine. Patients should not stop taking a prescribed course without medical advice; anyone holding the affected lot should contact their pharmacy or prescriber about a replacement supply.
The recalled product
- Product
- MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
- Brand
- MEMANTINE HYDROCHLORIDE
- Manufacturer
- The Harvard Drug Group LLC
- Category
- Drug — Extended-release capsule
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 # N02425
- Exp Date: 05/31/2027.
Distribution
Distributed nationwide across the United States.
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Similar recalls
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