The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1505-2020·Announced 2020-08-26

Ferring Recalls Desmopressin Acetate Nasal Spray Due to Superpotency

Ferring Pharmaceuticals is recalling 184,325 vials of Desmopressin Acetate Nasal Spray because the drug is superpotent. The recall is voluntary and nationwide.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical) regardless of other factors.

Plain-English summary

Ferring Pharmaceuticals Inc. is voluntarily recalling 184,325 vials of Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL. The product is a prescription-only medication manufactured for Amring Pharmaceuticals Inc. The recall was initiated on July 21, 2020, and the affected products were distributed nationwide within the United States.

The reason for the recall is that the drug is classified as "Superpotent." This means the medication contains a higher concentration of the active ingredient than intended. 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.

Patients who have received this medication should contact their healthcare provider for guidance. The recall covers specific lot numbers with expiration dates ranging from August 2020 to May 2022. The recall status is currently terminated.

The recalled product

Product
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, Rx only, Manufactured for: AMRING PHARMACEUTICALS INC., Berwyn, PA 19312, NDC 69918-501-05
Manufacturer
Ferring Pharmaceuticals Inc
Category
Drug — Nasal Spray
Hazard
Affected units
184,325

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 (18)

  • Lot #: N14695P
  • N14695S
  • exp. date 08 2020
  • N15627G
  • exp. date 10 2020 N15627GA
  • exp. date 10 2020 P10422A
  • exp. date 01 2021 P10422AA
  • exp. date 01 2021 P10430G
  • exp. date 03 2021 P11319M
  • exp. date 01 2021 P12969H
  • exp. date 05 2021 P12969IR
  • exp. date 05 2021 P13216G
  • exp. date 05 2021 P13216P
  • exp. date 05 2021 R11842A
  • exp. date 03 2022 R11842S
  • exp. date 03 2022 R12630A
  • exp. date 05 2022 R13071H
  • exp. date 04 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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