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Recall Observatory FDA recall evidence

Drug product

Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-550-25

D-0637-2023

May 02, 2023

Class II

Product summary

Firm
Apollo Care, LLC
Event
Event 92348
Status
Ongoing
Classification
Class II
Quantity
1617 bags
Official record key
drug-enforcement:D-0637-2023

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot#: AC-016631, Exp. Date 05/29/2023; AC-016655, Exp. Date 08/07/2023

Distribution pattern: Missouri only

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility