STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, M...
FDA Drug Recall #D-1506-2020 — Class I — July 21, 2020
Recall Summary
| Recall Number | D-1506-2020 |
| 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 | 29,371 nasal sprays |
Product Description
STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, Manufactured for: CSL Behring LLC, King of Prussia, PA 19406-0901; By: Ferring GmbH, Kiel, Germany, NDC 0053-6871-00
Reason for Recall
Superpotent Drug
Distribution Pattern
Nationwide within the United States.
Lot / Code Information
Lot # N14134C, exp. date 07 2020 N15378G, exp. date 09 2020 N17445N, exp. date 02 2020 P11326AA, exp. date 02 2021 P11326C, exp. date 02 2021 P13209L, exp. date 04 2021 P13212H, exp. date 06 2021 P13755A, exp. date 06 2021 P13756P, exp. date 08 2021 R11845A, exp. date 04 2022 R13271A, exp. date 04 2022 R13648A, exp. date 06 2022 R14101A, exp. date 07 2022 R14667A, exp. date 08 2022 R15953C, exp. date 09 2022
Other Recalls from Ferring Pharmaceuticals Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| 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-1505-2020 | Class I | Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL,... | 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.