Desmopressin Acetate Nasal Spray 10 microgram/0.1 millilliter

On August 5, 2020, Amring Pharmaceuticals, manufacturer of Desmopressin Acetate Nasal Spray, issued a voluntary recall of all lots on the market.

October 23, 2020  

These products are being recalled due to superpotency or amounts of desmopressin higher than specified, which may represent a potential safety risk.

What do you need to do?

  • Do not stop taking your medication without speaking with your doctor.  The U.S. Food and Drug Administration (FDA) recommends that patients continue taking their medication, as the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
  • Please call your doctor right away to obtain a new prescription for another appropriate medication. Your doctor will be able to prescribe another medication for you so you can continue treating your condition without interruption

To get more information or to report any adverse events or quality problems experienced with the use of this product, you can contact Amring Pharmaceuticals directly, or you can report to the FDA's MedWatch Program.

  • Manufacturer Information:

Amring Pharmaceuticals:
844.AMRING1 (844.267.4641)
Email:  amring@icsconnect.com

  • To report an adverse event to the FDA Med Watch Program:

Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda

Regular Mail or Fax: Download form https://www.fda.gov/safety/medical-product-safety-information/forms-reporting-fda mail or submit by fax to 800.FDA.0178

Affected NDCs:

 

Lot

Exp Date

NDC #

Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5 mL

N14695P

08/2020

69918-501-05

N14695S

08/2020

69918-501-05

N15627G

10/2020

69918-501-05

N15627GA

10/2020

69918-501-05

P10422A

01/2021

69918-501-05

P10422AA

01/2021

69918-501-05

P10430G

03/2021

69918-501-05

P11319M

01/2021

69918-501-05

P12969H

05/2021

69918-501-05

P12969IR

05/2021

69918-501-05

P13216G

05/2021

69918-501-05

P13216P

05/2021

69918-501-05

R11842A

03/2022

69918-501-05

R11842S

03/2022

69918-501-05

R12630A

05/2022

69918-501-05

R13071H

04/2022

69918-501-05