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Recall Observatory FDA recall evidence

Drug product

Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141

D-0906-2017

February 17, 2017

Class III

Product summary

Firm
Pharmedium Services, LLC
Event
Event 77191
Status
Terminated
Classification
Class III
Quantity
216 bags
Official record key
drug-enforcement:D-0906-2017

Official wording

Reason: Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Code information: Lot Numbers: 70090135M, 2/27/2017; 170250101M, 3/15/2017; 170030011D, 4/4/2017; 170040078D, 4/5/2017; 170310012D, 5/2/2017; 170400046D, 5/11/2017;

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Not Elsewhere Classified: Incorrect