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Recall Observatory FDA recall evidence

Drug 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

D-1505-2020

July 21, 2020

Class I

Product summary

Firm
Ferring Pharmaceuticals Inc
Event
Event 86066
Status
Terminated
Classification
Class I
Quantity
184,325 nasal sprays
Official record key
drug-enforcement:D-1505-2020

Official wording

Reason: Superpotent Drug

Code information: 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 pattern: Nationwide within the United States.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent