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Recall Observatory FDA recall evidence

Drug product

MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10

D-0575-2018

January 05, 2018

Class I

Product summary

Firm
Advanced Pharma Inc.
Event
Event 78889
Status
Terminated
Classification
Class I
Quantity
25 bags
Official record key
drug-enforcement:D-0575-2018

Official wording

Reason: Subpotent

Code information: Lot: 12/22/17 1422 108-90710P UD: 3/22/2018

Distribution pattern: Texas

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent