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Recall Observatory FDA recall evidence

Drug product

Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-836-11, Service Code 2K5836.

D-0976-2016

May 16, 2016

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 74299
Status
Terminated
Classification
Class II
Quantity
240 bags
Official record key
drug-enforcement:D-0976-2016

Official wording

Reason: Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.

Code information: Lot# 161300033M, Exp 07/26/16

Distribution pattern: NY

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.