AMANTADINE HYDROCHLORIDE
Generic: AMANTADINE HYDROCHLORIDE
Zhejiang Jutai Pharmaceutical Co.Manufacturer
ORALRoute
AMANTADINE HYDROCHLORIDEActive Substance
2024-09-26Original Approval
AMANTADINE HYDROCHLORIDE is FDA application ANDA218598, sponsored by ZHEJIANG JUTAI PHARM. 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 II2026-02-13
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification fin
Class II2018-03-30
Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN Failed Dissolution Specifications
Class II2021-03-15
Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Top Reported Reactions
1
FALL
1,743 reports
2
DRUG INEFFECTIVE
1,357 reports
3
FATIGUE
1,232 reports
4
HALLUCINATION
1,168 reports
5
DYSKINESIA
1,043 reports
6
GAIT DISTURBANCE
1,043 reports
7
DIZZINESS
883 reports
8
TREMOR
838 reports
9
DEATH
770 reports
10
ASTHENIA
750 reports