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Recall Observatory FDA recall evidence

Drug product

PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

D-1559-2014

May 28, 2014

Class I

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 68532
Status
Terminated
Classification
Class I
Quantity
1 dose
Official record key
drug-enforcement:D-1559-2014

Official wording

Reason: Non Sterility; microbial contamination identified as Aspergillus species

Code information: Lot # 13-920741-0-1 EXP 21 JUN 2014

Distribution pattern: Michigan and Wisconsin

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial contamination