Drugplain

Desmopressin Acetate 4 ug/mL

Desmopressin Acetate · INJECTION, SOLUTION · Fresenius Kabi USA, LLC

10 Recalls on Record
Plain English

Desmopressin acetate is an injectable medication that replaces a natural hormone in your body to help control bedwetting, manage certain types of bleeding disorders, and treat diabetes insipidus. It works by helping your body retain water and regulate fluid balance.

Key Facts

Brand Name
Desmopressin Acetate
Generic Name
Desmopressin Acetate
NDC Code (Product)
65219-293
Manufacturer
Fresenius Kabi USA, LLC
Strength
4 ug/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS, SUBCUTANEOUS
Marketing Status
Application #
ANDA216922
Marketing Start
09/11/2023

Recall History

10 Recalls on Record
Class III06/26/2015

American Health Packaging

Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.

TerminatedVoluntary: Firm initiated
Class I07/21/2020

Ferring Pharmaceuticals Inc

Superpotent Drug

TerminatedVoluntary: Firm initiated
Class II11/23/2022

Heritage Pharmaceuticals Inc

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class I07/21/2020

Ferring Pharmaceuticals Inc

Superpotent Drug

TerminatedVoluntary: Firm initiated
Class II02/10/2021

Teva Pharmaceuticals USA

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

TerminatedVoluntary: Firm initiated
Class III06/23/2015

Actavis Laboratories, FL, Inc.

Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.

TerminatedVoluntary: Firm initiated
Class II02/07/2020

American Health Packaging

GMP Deviations: Product bottle may be absent of desiccant.

TerminatedVoluntary: Firm initiated
Class II02/07/2020

American Health Packaging

GMP Deviations: Product bottle may be absent of desiccant.

TerminatedVoluntary: Firm initiated
Class II01/27/2020

Teva Pharmaceuticals USA

GMP Deviations: Product bottle may be absent of desiccant.

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

Side Effects Reported to FDA

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

hyponatraemia214 reports
drug ineffective131 reports
headache90 reports
nausea90 reports
off label use77 reports
vomiting75 reports
fatigue71 reports
pain55 reports
diarrhoea53 reports
condition aggravated52 reports

Frequently Asked Questions

What is Desmopressin Acetate used for?

Desmopressin acetate is an injectable medication that replaces a natural hormone in your body to help control bedwetting, manage certain types of bleeding disorders, and treat diabetes insipidus. It works by helping your body retain water and regulate fluid balance.

Is Desmopressin Acetate a controlled substance?

Desmopressin Acetate is not classified as a controlled substance by the DEA.

What is the generic name for Desmopressin Acetate?

The generic name for Desmopressin Acetate is Desmopressin Acetate. There are 5 other brand versions of Desmopressin Acetate.

What is the NDC code for Desmopressin Acetate 4 ug/mL?

The NDC (National Drug Code) for Desmopressin Acetate 4 ug/mL is 65219-293, listed by Fresenius Kabi USA, LLC.