MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE

Generic: MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE

Vitruvias TherapeuticsManufacturer
ORALRoute
MEMANTINE HYDROCHLORIDEActive Substance
2025-07-15Original Approval

MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE is FDA application ANDA216901, sponsored by XIAMEN LP PHARM CO. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2020-02-12
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuti

Failed Dissolution Specifications: Low out of specification results observed in dissolution test at

Class II2026-03-24
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Di

Failed Dissolution Specifications

Class III2020-04-24
Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by:

Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stabi

Class III2019-12-13
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured

Failed Dissolution Specifications: High out of specification result observed at stability studies.

Class III2019-12-10
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-co

Failed Dissolution Specifications: High out of specification result observed at stability studies.

Top Reported Reactions

1
FALL
996 reports
2
DEATH
917 reports
3
DRUG INEFFECTIVE
861 reports
4
OFF LABEL USE
782 reports
5
CONFUSIONAL STATE
739 reports
6
FATIGUE
646 reports
7
HALLUCINATION
632 reports
8
CONDITION AGGRAVATED
533 reports
9
ASTHENIA
487 reports
10
DIZZINESS
464 reports