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Recall Observatory FDA recall evidence

Drug product

Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Service Code 2K5288, NDC# 61553-0288-48, Total Volume 100.00 mL incorrectly labeled as 103.33 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

D-0911-2017

February 17, 2017

Class III

Product summary

Firm
Pharmedium Services, LLC
Event
Event 77191
Status
Terminated
Classification
Class III
Quantity
672 bags
Official record key
drug-enforcement:D-0911-2017

Official wording

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

Code information: Lot Numbers: 163640076D, 3/30/2017; 170040009D, 4/5/2017; 170040224S, 4/5/2017; 170040065S, 4/5/2017; 170050068D, 4/6/2017; 170060353S, 4/9/2017; 170100076D, 4/11/2017; 170100111S, 4/11/2017; 170120090D, 4/13/2017; 170120154S, 4/13/2017; 170160150S, 4/17/2017; 170260005D, 4/27/2017; 170380110S, 5/9/2017; 170400085S, 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