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Recall Observatory FDA recall evidence

Drug product

Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1.

D-0325-2024

January 22, 2024

Class II

Product summary

Firm
IntegraDose Compounding Services LLC
Event
Event 93940
Status
Ongoing
Classification
Class II
Quantity
1,299 syringes
Official record key
drug-enforcement:D-0325-2024

Official wording

Reason: Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.

Code information: Lot #s: 20230929VAS-2, Exp. 02/29/2024; 20231004VAS-2, Exp. 04/01/2024; Lot 20231010VAS-2,Exp. 04/07/2024; Lot 20231013VAS-2, Exp. 04/10/2024

Distribution pattern: MN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.