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Recall Observatory FDA recall evidence

Drug product

Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Service Code 2K5295, NDC# 61553-0295-48, Total Volume 100.00 mL incorrectly labeled as105.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

D-0910-2017

February 17, 2017

Class III

Product summary

Firm
Pharmedium Services, LLC
Event
Event 77191
Status
Terminated
Classification
Class III
Quantity
912 bags
Official record key
drug-enforcement:D-0910-2017

Official wording

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

Code information: Lot Numbers: 170050001D, 4/5/2017; 170040025D, 4/5/2017; 170060046D, 4/9/2017; 170090062D, 4/10/2017; 170110125S, 4/12/2017; 170170016S, 4/18/2017; 170200120S, 4/23/2017; 170380108S, 5/9/2017;

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Not Elsewhere Classified: Incorrect