CHLORPROMAZINE HYDROCHLORIDE

Generic: CHLORPROMAZINE HYDROCHLORIDE

Novadoz Pharmaceuticals LLCManufacturer
ORALRoute
CHLORPROMAZINE HYDROCHLORIDEActive Substance
2022-01-27Original Approval

CHLORPROMAZINE HYDROCHLORIDE is FDA application ANDA214827, sponsored by MSN. 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 II2025-09-03
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable int

Class II2024-12-11
chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals I

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per cu

Class II2025-09-03
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable int

Class II2025-09-03
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable int

Class II2025-04-03
chlorproMAZINE Hydrochloride Tablets, USP 10 mg, Rx Only, 100 Tablets bottles, Manufactured by: Zydus Lifesciences Ltd.,

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended inter

Class II2025-09-03
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., B

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable int

Class II2025-09-03
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd.,

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable int

Class II2025-08-25
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare

Presence of a foreign substance.

Class II2025-08-18
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pv

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packagin

Class II2025-08-18
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals P

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packagin

Top Reported Reactions

1
DRUG INEFFECTIVE
544 reports
2
TOXICITY TO VARIOUS AGENTS
458 reports
3
OFF LABEL USE
449 reports
4
OVERDOSE
354 reports
5
DRUG INTERACTION
326 reports
6
NEUROLEPTIC MALIGNANT SYNDROME
294 reports
7
NAUSEA
275 reports
8
NEUTROPENIA
271 reports
9
DIARRHOEA
256 reports
10
FATIGUE
253 reports