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Recall Observatory FDA recall evidence

Drug product

Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.

D-0615-2018

March 07, 2018

Class II

Product summary

Firm
Apollo Care
Event
Event 79517
Status
Terminated
Classification
Class II
Quantity
96 bags
Official record key
drug-enforcement:D-0615-2018

Official wording

Reason: Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.

Code information: Lot#: AC-015569, Exp. 03/26/2018

Distribution pattern: Medical Facility in MO

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Stability Data Does Not Support Expiry