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Recall Observatory FDA recall evidence

Drug product

VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Code 2K2243, NDC# 61553-043-34, Total Volume 300.00 mL incorrectly labeled as 500.00 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478

D-0914-2017

February 17, 2017

Class II

Product summary

Firm
Pharmedium Services, LLC
Event
Event 77191
Status
Terminated
Classification
Class II
Quantity
816 bags
Official record key
drug-enforcement:D-0914-2017

Official wording

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

Code information: Lot Numbers: 170200039S, 2/22/2017; 170230182S, 170230137S, 2/23/2017; 170260122S, 2/26/2017; 170300085S, 3/2/2017; 170320048S, 3/4/2017; 170340152S, 3/8/2017; 170380097S, 3/10/2017

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Not Elsewhere Classified: Incorrect