FLUPHENAZINE HYDROCHLORIDE
Generic: FLUPHENAZINE HYDROCHLORIDE
Sun Pharmaceutical IndustriesManufacturer
ORALRoute
FLUPHENAZINE HYDROCHLORIDEActive Substance
2022-04-14Original Approval
FLUPHENAZINE HYDROCHLORIDE is FDA application ANDA215674, sponsored by TARO. 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 II2025-03-13
Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, CGMP Deviations
Class III2026-08-25
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., BridgewaFailed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) duri
Class II2025-03-13
Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, CGMP Deviations
Top Reported Reactions
1
SEDATION
19 reports
2
DRUG INEFFECTIVE
16 reports
3
ANXIETY
13 reports
4
SUICIDE ATTEMPT
12 reports
5
SCHIZOPHRENIA
11 reports
6
BLOOD PRESSURE DECREASED
10 reports
7
BLOOD PRESSURE INCREASED
10 reports
8
CHEST PAIN
10 reports
9
PARKINSONISM
10 reports
10
DYSPNOEA
9 reports