Drugplain

Neostigmine methylsulfate .5 mg/mL

Neostigmine methylsulfate · INJECTION · Amneal Pharmaceuticals LLC

10 Recalls on RecordCurrently in Shortage
Plain English

Neostigmine methylsulfate is a injection containing neostigmine methylsulfate at .5 mg/mL, taken intravenous. Manufactured by Amneal Pharmaceuticals LLC.

Key Facts

Brand Name
Neostigmine methylsulfate
Generic Name
Neostigmine methylsulfate
NDC Code (Product)
70121-1478
Manufacturer
Amneal Pharmaceuticals LLC
Strength
.5 mg/mL
Dosage Form
INJECTION
Route
INTRAVENOUS
Marketing Status
Application #
ANDA210051
Marketing Start
06/20/2018

Recall History

10 Recalls on Record
Class III11/25/2020

US Compounding Inc

Labelling: Missing label.

TerminatedVoluntary: Firm initiated
Class II09/12/2019

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II04/11/2018

Premier Pharmacy Labs Inc

Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

TerminatedVoluntary: Firm initiated
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated
Class II09/12/2019

KRS Global Biotechnology, Inc

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II07/14/2017

Cantrell Drug Company

Lack of Sterility Assurance.

TerminatedVoluntary: Firm initiated
Class II02/22/2017

Advanced Pharma Inc.

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

TerminatedVoluntary: Firm initiated
Class II06/30/2022

Nephron Sterile Compounding Center LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II06/18/2019

Premier Pharmacy Labs Inc

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

TerminatedVoluntary: Firm initiated
Class II11/10/2022

Nephron Sterile Compounding Center LLC

CGMP Deviations: Potential for cross contamination due to product carry over.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective34 reports
abdominal distension25 reports
nausea23 reports
hypotension22 reports
abdominal pain19 reports
respiratory failure19 reports
white blood cell count increased18 reports
cardiac arrest16 reports
pyrexia16 reports
bradycardia15 reports

Frequently Asked Questions

What is Neostigmine methylsulfate used for?

Neostigmine methylsulfate contains Neostigmine methylsulfate. It is a injection taken intravenous. Consult your doctor for specific uses.

Is Neostigmine methylsulfate a controlled substance?

Neostigmine methylsulfate is not classified as a controlled substance by the DEA.

What is the generic name for Neostigmine methylsulfate?

The generic name for Neostigmine methylsulfate is Neostigmine methylsulfate. There are 11 other brand versions of Neostigmine methylsulfate.

What is the NDC code for Neostigmine methylsulfate .5 mg/mL?

The NDC (National Drug Code) for Neostigmine methylsulfate .5 mg/mL is 70121-1478, listed by Amneal Pharmaceuticals LLC.