DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring P...

FDA Drug Recall #D-1504-2020 — Class I — July 21, 2020

Recall Summary

Recall Number D-1504-2020
Classification Class I — Serious risk
Date Initiated July 21, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ferring Pharmaceuticals Inc
Location Parsippany, NJ
Product Type Drugs
Quantity 15,175 nasal sprays

Product Description

DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 USA, NDC 55566-2500-0

Reason for Recall

Superpotent Drug

Distribution Pattern

Nationwide within the United States.

Lot / Code Information

Lot #: N14695F, exp. date 08/2020 N15627C, exp. date 10/2020 P11319P, exp. date 01/2021 P11706F, exp. date 04/2021 R11842C, exp. date 03/2022; R13637E, exp. date 06/2022

Other Recalls from Ferring Pharmaceuticals Inc

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D-0879-2023 Class II Endometrin (progesterone) Vaginal Insert 100mg,... Jun 12, 2023
D-0318-2021 Class II ZOMA-Jet 10 Demonstration Kit, Needle-free deli... Mar 11, 2021
D-0317-2021 Class II ZOMA-Jet 5 Demonstration Kit, Needle-free deliv... Mar 11, 2021
D-0299-2021 Class III Menopur 75 IU, (menotropins for injection), pac... Mar 2, 2021
D-1506-2020 Class I STIMATE (desmopressin acetate) Nasal Spray1.5 m... Jul 21, 2020

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.