FDA Recall D-1505-2020

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

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

Lot / code: 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

Quantity: 184,325 nasal sprays

Reason for recall

Superpotent Drug

Recall record

Recall number: D-1505-2020
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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