FDA Recall D-1506-2020

Ferring Pharmaceuticals Inc · Parsippany, NJ

Class I — life-threatening Terminated 1179 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

Lot / code: 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

Quantity: 29,371 nasal sprays

Reason for recall

Superpotent Drug

Recall record

Recall number: D-1506-2020
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States.
Recall initiated: 2020-07-21
Classified by FDA Center: 2020-08-17
FDA published: 2020-08-26
Terminated: 2023-10-13
Recalling firm: Ferring Pharmaceuticals Inc
Firm location: Parsippany, NJ

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