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VANCOMYCIN HYDROCHLORIDE 5.13 g/g

vancomycin hydrochloride · INJECTION, POWDER, FOR SOLUTION · HIKMA PHARMACEUTICALS USA INC.

10 Recalls on RecordCurrently in Shortage
Plain English

Vancomycin hydrochloride is an antibiotic injection used to treat serious bacterial infections, particularly those caused by resistant bacteria like methicillin-resistant Staphylococcus aureus (MRSA). It is administered intravenously by a healthcare provider in a hospital or clinical setting.

Key Facts

Brand Name
VANCOMYCIN HYDROCHLORIDE
Generic Name
vancomycin hydrochloride
NDC Code (Product)
0143-9163
Manufacturer
HIKMA PHARMACEUTICALS USA INC.
Strength
5.13 g/g
Dosage Form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS, ORAL
Marketing Status
Application #
NDA210274
Marketing Start
02/03/2023

Recall History

10 Recalls on Record
Class II05/16/2014

Actavis Inc

Subpotent Drug.

TerminatedVoluntary: Firm initiated
Class II11/25/2019

AuroMedics Pharma LLC

Discoloration: Product complaints of discoloration after reconstitution of vials.

TerminatedVoluntary: Firm initiated
Class I08/30/2017

Pfizer Inc.

Presence of Particulate Matter: glass particulate found in vial

TerminatedVoluntary: Firm initiated
Class II08/25/2014

Actavis Inc

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class I08/24/2021

Azurity Pharmaceuticals, Inc.

Product Mix-up: Incorrect diluent component included in the kit.

TerminatedVoluntary: Firm initiated
Class II08/25/2014

Actavis Inc

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class I12/22/2022

Pfizer Inc.

Presence of Particulate Matter: Glass particulate matter detected in injectable.

TerminatedVoluntary: Firm initiated
Class III11/07/2014

Hospira Inc.

Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.

TerminatedVoluntary: Firm initiated
Class II02/12/2015

Actavis Inc

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class II05/06/2016

Hospira Inc.

Presence of Particulate Matter: Cardboard

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective824 reports
acute kidney injury470 reports
off label use455 reports
pyrexia413 reports
rash296 reports
drug reaction with eosinophilia and systemic symptoms290 reports
drug hypersensitivity280 reports
condition aggravated263 reports
pneumonia258 reports
diarrhoea252 reports

Frequently Asked Questions

What is VANCOMYCIN HYDROCHLORIDE used for?

Vancomycin hydrochloride is an antibiotic injection used to treat serious bacterial infections, particularly those caused by resistant bacteria like methicillin-resistant Staphylococcus aureus (MRSA). It is administered intravenously by a healthcare provider in a hospital or clinical setting.

Is VANCOMYCIN HYDROCHLORIDE a controlled substance?

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

What is the generic name for VANCOMYCIN HYDROCHLORIDE?

The generic name for VANCOMYCIN HYDROCHLORIDE is vancomycin hydrochloride. There are 9 other brand versions of vancomycin hydrochloride.

What is the NDC code for VANCOMYCIN HYDROCHLORIDE 5.13 g/g?

The NDC (National Drug Code) for VANCOMYCIN HYDROCHLORIDE 5.13 g/g is 0143-9163, listed by HIKMA PHARMACEUTICALS USA INC..