Medications & Supplements/Prescription Drugs

Ferring Pharmaceuticals Inc: Nasal Sprays Recalled for Being Superpotent

Agency Publication Date: August 17, 2020

Summary

Ferring Pharmaceuticals Inc. is recalling approximately 228,871 units of DDAVP (desmopressin acetate) Nasal Spray, Desmopressin Acetate Nasal Spray, and STIMATE (desmopressin acetate) Nasal Spray. These medications, used to treat conditions like bedwetting, diabetes insipidus, and certain bleeding disorders, were found to be superpotent, meaning they contain a higher concentration of the active ingredient than specified. If you are using these products, contact your doctor or pharmacist immediately, as using a superpotent drug can lead to serious health complications.

Risk

The superpotent medication delivers a higher dose of desmopressin than intended, which can lead to dangerously low sodium levels in the blood (hyponatremia). This condition can cause severe symptoms including seizures, coma, or even death.

What You Should Do

Check your medication packaging to see if you have DDAVP Nasal Spray (NDC 55566-2500-0), Desmopressin Acetate Nasal Spray (NDC 69918-501-05), or STIMATE Nasal Spray (NDC 0053-6871-00).
If you have DDAVP Nasal Spray 10 mcg/0.1 mL, look for lot numbers N14695F (Exp 08/2020), N15627C (Exp 10/2020), P11319P (Exp 01/2021), P11706F (Exp 04/2021), R11842C (Exp 03/2022), or R13637E (Exp 06/2022).
If you have Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL (Amring), check for lot numbers N14695P, N14695S (Exp 08/2020), N15627G, N15627GA (Exp 10/2020), P10422A, P10422AA, P11319M (Exp 01/2021), P10430G (Exp 03/2021), R13071H (Exp 04/2022), P12969H, P12969IR, P13216G, P13216P (Exp 05/2021), R11842A, R11842S (Exp 03/2022), or R12630A (Exp 05/2022).
If you have STIMATE Nasal Spray 1.5 mg/mL, check for lot numbers N17445N (Exp 02/2020), N14134C (Exp 07/2020), N15378G (Exp 09/2020), P11326AA, P11326C (Exp 02/2021), P13209L (Exp 04/2021), P13212H, P13755A (Exp 06/2021), P13756P (Exp 08/2021), R11845A, R13271A (Exp 04/2022), R13648A (Exp 06/2022), R14101A (Exp 07/2022), R14667A (Exp 08/2022), or R15953C (Exp 09/2022).
Immediately contact your healthcare provider or pharmacist for guidance regarding your treatment and to obtain a safe replacement medication.
Return any unused product from the affected lots to your pharmacy for a refund and contact Ferring Pharmaceuticals for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL (5 mL)

Model:

NDC 55566-2500-0

Lot Numbers:

N14695F (Exp 08/2020)

N15627C (Exp 10/2020)

P11319P (Exp 01/2021)

P11706F (Exp 04/2021)

R11842C (Exp 03/2022)

R13637E (Exp 06/2022)

Product: Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL (5 mL)

Model:

NDC 69918-501-05

Lot Numbers:

N14695P (Exp 08/2020)

N14695S (Exp 08/2020)

N15627G (Exp 10/2020)

N15627GA (Exp 10/2020)

P10422A (Exp 01/2021)

P10422AA (Exp 01/2021)

P10430G (Exp 03/2021)

P11319M (Exp 01/2021)

P12969H (Exp 05/2021)

P12969IR (Exp 05/2021)

P13216G (Exp 05/2021)

P13216P (Exp 05/2021)

R11842A (Exp 03/2022)

R11842S (Exp 03/2022)

R12630A (Exp 05/2022)

R13071H (Exp 04/2022)

Product: STIMATE (desmopressin acetate) Nasal Spray 1.5 mg/mL (2.5 mL)

Model:

NDC 0053-6871-00

Lot Numbers:

N14134C (Exp 07/2020)

N15378G (Exp 09/2020)

N17445N (Exp 02/2020)

P11326AA (Exp 02/2021)

P11326C (Exp 02/2021)

P13209L (Exp 04/2021)

P13212H (Exp 06/2021)

P13755A (Exp 06/2021)

P13756P (Exp 08/2021)

R11845A (Exp 04/2022)

R13271A (Exp 04/2022)

R13648A (Exp 06/2022)

R14101A (Exp 07/2022)

R14667A (Exp 08/2022)

R15953C (Exp 09/2022)

Product Images

Label, DDAVP® Nasal Spray 10 mcg/0.1mL

Label, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL

Label, STIMATE® Nasal Spray 1.5 mg/mL

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86066

Status: Resolved

Manufacturer: Ferring Pharmaceuticals Inc

Sold By: Pharmacies

Manufactured In: United States, Germany

Units Affected: 3 products (15,175 nasal sprays; 184,325 nasal sprays; 29,371 nasal sprays)

Distributed To: Nationwide

Agency Last Updated: October 13, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication packaging to see if you have DDAVP Nasal Spray (NDC 55566-2500-0), Desmopressin Acetate Nasal Spray (NDC 69918-501-05), or STIMATE Nasal Spray (NDC 0053-6871-00).

If you have DDAVP Nasal Spray 10 mcg/0.1 mL, look for lot numbers N14695F (Exp 08/2020), N15627C (Exp 10/2020), P11319P (Exp 01/2021), P11706F (Exp 04/2021), R11842C (Exp 03/2022), or R13637E (Exp 06/2022).

If you have Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL (Amring), check for lot numbers N14695P, N14695S (Exp 08/2020), N15627G, N15627GA (Exp 10/2020), P10422A, P10422AA, P11319M (Exp 01/2021), P10430G (Exp 03/2021), R13071H (Exp 04/2022), P12969H, P12969IR, P13216G, P13216P (Exp 05/2021), R11842A, R11842S (Exp 03/2022), or R12630A (Exp 05/2022).

If you have STIMATE Nasal Spray 1.5 mg/mL, check for lot numbers N17445N (Exp 02/2020), N14134C (Exp 07/2020), N15378G (Exp 09/2020), P11326AA, P11326C (Exp 02/2021), P13209L (Exp 04/2021), P13212H, P13755A (Exp 06/2021), P13756P (Exp 08/2021), R11845A, R13271A (Exp 04/2022), R13648A (Exp 06/2022), R14101A (Exp 07/2022), R14667A (Exp 08/2022), or R15953C (Exp 09/2022).

Immediately contact your healthcare provider or pharmacist for guidance regarding your treatment and to obtain a safe replacement medication.

Return any unused product from the affected lots to your pharmacy for a refund and contact Ferring Pharmaceuticals for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL (5 mL)

Model:

NDC 55566-2500-0

Lot Numbers:

N14695F (Exp 08/2020)

N15627C (Exp 10/2020)

P11319P (Exp 01/2021)

P11706F (Exp 04/2021)

R11842C (Exp 03/2022)

R13637E (Exp 06/2022)

Product: Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL (5 mL)

Model:

NDC 69918-501-05

Lot Numbers:

N14695P (Exp 08/2020)

N14695S (Exp 08/2020)

N15627G (Exp 10/2020)

N15627GA (Exp 10/2020)

P10422A (Exp 01/2021)

P10422AA (Exp 01/2021)

P10430G (Exp 03/2021)

P11319M (Exp 01/2021)

P12969H (Exp 05/2021)

P12969IR (Exp 05/2021)

P13216G (Exp 05/2021)

P13216P (Exp 05/2021)

R11842A (Exp 03/2022)

R11842S (Exp 03/2022)

R12630A (Exp 05/2022)

R13071H (Exp 04/2022)

Product: STIMATE (desmopressin acetate) Nasal Spray 1.5 mg/mL (2.5 mL)

Model:

NDC 0053-6871-00

Lot Numbers:

N14134C (Exp 07/2020)

N15378G (Exp 09/2020)

N17445N (Exp 02/2020)

P11326AA (Exp 02/2021)

P11326C (Exp 02/2021)

P13209L (Exp 04/2021)

P13212H (Exp 06/2021)

P13755A (Exp 06/2021)

P13756P (Exp 08/2021)

R11845A (Exp 04/2022)

R13271A (Exp 04/2022)

R13648A (Exp 06/2022)

R14101A (Exp 07/2022)

R14667A (Exp 08/2022)

R15953C (Exp 09/2022)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86066

Status: Resolved

Manufacturer: Ferring Pharmaceuticals Inc

Sold By: Pharmacies

Manufactured In: United States, Germany

Units Affected: 3 products (15,175 nasal sprays; 184,325 nasal sprays; 29,371 nasal sprays)

Distributed To: Nationwide

Agency Last Updated: October 13, 2023