The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1504-2020·Announced 2020-08-26

Ferring Recalls DDAVP Nasal Spray Due to Superpotent Drug Risk

Ferring Pharmaceuticals is recalling 15,175 bottles of DDAVP Nasal Spray because the drug may be 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 FDA classified this recall as Class I, which is the most serious classification indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

Plain-English summary

Ferring Pharmaceuticals Inc. is voluntarily recalling 15,175 bottles of DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles. The product is prescription-only and was distributed nationwide within the United States.

The recall was initiated because the drug is considered superpotent. A superpotent drug is one where a small error in the amount of active ingredient can result in a significant deviation from the labeled strength, potentially leading to serious adverse health consequences. The affected lots include N14695F, N15627C, P11319P, P11706F, R11842C, and R13637E, with expiration dates ranging from August 2020 to June 2022.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance. The recall was initiated on July 21, 2020, and was terminated on October 13, 2023.

The recalled product

Product
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
Manufacturer
Ferring Pharmaceuticals Inc
Category
Drug — Nasal Spray
Hazard
Affected units
15,175

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 (8)

  • 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

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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