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Recall Observatory FDA recall evidence

Drug product

Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141

D-0907-2017

February 17, 2017

Class III

Product summary

Firm
Pharmedium Services, LLC
Event
Event 77191
Status
Terminated
Classification
Class III
Quantity
143 bags
Official record key
drug-enforcement:D-0907-2017

Official wording

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

Code information: Lot Numbers: 163640167M, 3/21/2017; 170050171M, 3/28/2017; 170070172M, 3/31/2017;170190235M, 4/11/2017; 170200120M, 4/14/2017; 170230115M, 4/15/2017; 170390059D, 5/10/2017;

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Not Elsewhere Classified: Incorrect