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Recall Observatory FDA recall evidence

Drug product

Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-237-10

D-0232-2024

January 11, 2024

Class II

Product summary

Firm
Par Sterile Products LLC
Event
Event 93805
Status
Ongoing
Classification
Class II
Quantity
1721 cartons
Official record key
drug-enforcement:D-0232-2024

Official wording

Reason: Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.

Code information: Lot # 66702; Exp. 02/2025

Distribution pattern: Nationwide USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent