Drugplain

CHLORPROMAZINE HYDROCHLORIDE 25 mg/mL

CHLORPROMAZINE HYDROCHLORIDE · INJECTION · Fresenius Kabi USA, LLC

10 Recalls on Record
Plain English

CHLORPROMAZINE HYDROCHLORIDE is a injection containing chlorpromazine hydrochloride at 25 mg/mL, taken intramuscular. Manufactured by Fresenius Kabi USA, LLC.

Key Facts

Brand Name
CHLORPROMAZINE HYDROCHLORIDE
Generic Name
CHLORPROMAZINE HYDROCHLORIDE
NDC Code (Product)
65219-130
Manufacturer
Fresenius Kabi USA, LLC
Strength
25 mg/mL
Dosage Form
INJECTION
Route
INTRAMUSCULAR
Marketing Status
Application #
ANDA216724
Marketing Start
02/15/2025

Recall History

10 Recalls on Record
Class II09/03/2025

Zydus Pharmaceuticals (USA) Inc

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

OngoingVoluntary: Firm initiated
Class II12/11/2024

Glenmark Pharmaceuticals Inc., USA

CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.

OngoingVoluntary: Firm initiated
Class II08/27/2025

Amerisource Health Services LLC

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

OngoingVoluntary: Firm initiated
Class II09/03/2025

Zydus Pharmaceuticals (USA) Inc

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

OngoingVoluntary: Firm initiated
Class II09/03/2025

Zydus Pharmaceuticals (USA) Inc

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

OngoingVoluntary: Firm initiated
Class II04/03/2025

Zydus Pharmaceuticals (USA) Inc

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

OngoingVoluntary: Firm initiated
Class II09/03/2025

Zydus Pharmaceuticals (USA) Inc

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

OngoingVoluntary: Firm initiated
Class II09/03/2025

Zydus Pharmaceuticals (USA) Inc

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

OngoingVoluntary: Firm initiated
Class II08/27/2025

Amerisource Health Services LLC

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

OngoingVoluntary: Firm initiated
Class II09/12/2025

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective536 reports
off label use445 reports
toxicity to various agents445 reports
overdose356 reports
drug interaction324 reports
neuroleptic malignant syndrome293 reports
nausea275 reports
neutropenia265 reports
diarrhoea256 reports
fatigue253 reports

Frequently Asked Questions

What is CHLORPROMAZINE HYDROCHLORIDE used for?

CHLORPROMAZINE HYDROCHLORIDE contains CHLORPROMAZINE HYDROCHLORIDE. It is a injection taken intramuscular. Consult your doctor for specific uses.

Is CHLORPROMAZINE HYDROCHLORIDE a controlled substance?

CHLORPROMAZINE HYDROCHLORIDE is not classified as a controlled substance by the DEA.

What is the generic name for CHLORPROMAZINE HYDROCHLORIDE?

The generic name for CHLORPROMAZINE HYDROCHLORIDE is CHLORPROMAZINE HYDROCHLORIDE. There are 11 other brand versions of CHLORPROMAZINE HYDROCHLORIDE.

What is the NDC code for CHLORPROMAZINE HYDROCHLORIDE 25 mg/mL?

The NDC (National Drug Code) for CHLORPROMAZINE HYDROCHLORIDE 25 mg/mL is 65219-130, listed by Fresenius Kabi USA, LLC.