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Recall Observatory FDA recall evidence

Drug product

VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO 65202. NDC 71170-185-50

D-0636-2023

May 02, 2023

Class II

Product summary

Firm
Apollo Care, LLC
Event
Event 92348
Status
Ongoing
Classification
Class II
Quantity
2040 bags
Official record key
drug-enforcement:D-0636-2023

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot#: AC-016629, Exp. Date 05/13/2023; AC-016646, Exp. Date 06/24/2023

Distribution pattern: Missouri only

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility