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Class I: serious health riskTerminated

Ferring Pharmaceuticals Stimate Recall

STIMATE (desmopressin acetate) Nasal Spray1

Ferring Pharmaceuticals Inc · Parsippany, NJ

Risk level
Class I
Reported by FDA
Aug 26, 2020
Recall ID
D-1506-2020
Check your lot numberHow we source this data

Summary

Ferring Pharmaceuticals recalled Stimate starting Jul 21, 2020. The FDA classified it as Class I (serious health risk) and published enforcement report D-1506-2020 on Aug 26, 2020. Reason: Superpotent Drug. Status: Terminated.

Why it was recalled

Superpotent Drug

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide within the United States.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1506-2020
Classification
Class I
Status
Terminated
Recall initiated
Jul 21, 2020
FDA report date
Aug 26, 2020
Quantity
29,371 nasal sprays
Recall type
Voluntary: Firm initiated
Recalling firm
Ferring Pharmaceuticals Inc

Original FDA data

Every field from FDA enforcement report D-1506-2020, exactly as published.

Show all FDA fields
City
Parsippany
State
NJ
Status
Terminated
Country
United States
Event ID
86066
Address
100 Interpace Pkwy
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
Postal code
07054-1149
Report date
Aug 26, 2020
Product type
Drugs
Recall number
D-1506-2020
Classification
Class I
Recalling firm
Ferring Pharmaceuticals Inc
Product quantity
29,371 nasal sprays
Termination date
Oct 13, 2023
Reason for recall
Superpotent Drug
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide within the United States.
Recall initiation date
Jul 21, 2020
Initial firm notification
Letter
Center classification date
Aug 17, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1506-2020, published Aug 26, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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