Drugplain

Estradiol valerate 20 mg/mL

Estradiol valerate · INJECTION · Xiromed, LLC

10 Recalls on RecordCurrently in Shortage
Plain English

Estradiol valerate is a injection containing estradiol valerate at 20 mg/mL, taken intramuscular. Manufactured by Xiromed, LLC.

Key Facts

Brand Name
Estradiol valerate
Generic Name
Estradiol valerate
NDC Code (Product)
70700-274
Manufacturer
Xiromed, LLC
Strength
20 mg/mL
Dosage Form
INJECTION
Route
INTRAMUSCULAR
Marketing Status
Application #
ANDA216656
Marketing Start
05/01/2023

Recall History

10 Recalls on Record
Class II10/12/2021

Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Lack of assurance of sterility

TerminatedVoluntary: Firm initiated
Class II04/10/2013

FVS Holdings, Inc. dba. Green Valley Drugs

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

TerminatedVoluntary: Firm initiated
Class II10/12/2021

Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Lack of assurance of sterility

TerminatedVoluntary: Firm initiated
Class II06/02/2015

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

TerminatedVoluntary: Firm initiated
Class II10/12/2021

Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Lack of assurance of sterility

TerminatedVoluntary: Firm initiated
Class II03/20/2013

Clinical Specialties Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

TerminatedVoluntary: Firm initiated
Class II07/26/2013

Beacon Hill Medical Pharmacy, P.C.

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

TerminatedVoluntary: Firm initiated
Class II10/12/2021

Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Lack of assurance of sterility

TerminatedVoluntary: Firm initiated
Class II08/13/2021

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

TerminatedVoluntary: Firm initiated
Class II05/28/2013

Main Street Family Pharmacy, LLC

The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use69 reports
headache60 reports
fatigue51 reports
drug ineffective46 reports
nausea42 reports
dyspnoea39 reports
migraine39 reports
pain37 reports
weight increased32 reports
diarrhoea29 reports

Frequently Asked Questions

What is Estradiol valerate used for?

Estradiol valerate contains Estradiol valerate. It is a injection taken intramuscular. Consult your doctor for specific uses.

Is Estradiol valerate a controlled substance?

Estradiol valerate is not classified as a controlled substance by the DEA.

What is the generic name for Estradiol valerate?

The generic name for Estradiol valerate is Estradiol valerate. There are 9 other brand versions of Estradiol valerate.

What is the NDC code for Estradiol valerate 20 mg/mL?

The NDC (National Drug Code) for Estradiol valerate 20 mg/mL is 70700-274, listed by Xiromed, LLC.