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Recall Observatory FDA recall evidence

Drug product

Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5284 NDC# 61553-284-48

D-0991-2017

June 26, 2017

Class II

Product summary

Firm
PharMedium Services, Llc
Event
Event 77634
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0991-2017

Official wording

Reason: Lack of Assurance of Sterility; media fill failure at manufacturer

Code information: Lots: 171220061D Exp. 8/1/2017, 171250023D Exp. 8/6/2017, 171430008D Exp. 8/22/2017, 171450015D Exp. 8/24/2017, 171510062D Exp. 8/30/2017

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility