The Recall Desk
CriticalFDA (Drugs)·D-1506-2020·Announced 2020-08-26

Ferring Recalls STIMATE Nasal Spray Due to Superpotent Drug Risk

Ferring Pharmaceuticals is recalling 29,371 vials of STIMATE nasal spray because the drug is superpotent. The recall is voluntary and nationwide.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA classified this recall as Class I, which per the rubric mandates a severity score of 5 (Critical) regardless of other factors.

Plain-English summary

Ferring Pharmaceuticals Inc is voluntarily recalling 29,371 vials of STIMATE (desmopressin acetate) Nasal Spray, 1.5 mg/mL, 2.5 mL glass vial with spray cap. The product is prescription-only and was manufactured for CSL Behring LLC by Ferring GmbH in Kiel, Germany. The recall was initiated on July 21, 2020, and the product was distributed nationwide within the United States.

The reason for the recall is that the drug is classified as "Superpotent Drug." The FDA has classified this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Specific lot numbers and expiration dates are listed in the official recall notice, ranging from expiration dates in 2020 to 2022.

Patients and healthcare providers should stop using the affected STIMATE nasal spray vials and contact their healthcare provider for guidance on alternative treatment. The recall was terminated on October 13, 2023.

The recalled product

Product
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
Manufacturer
Ferring Pharmaceuticals Inc
Category
Drug — Nasal Spray
Hazard
Affected units
29,371

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Ferring Pharmaceuticals Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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