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Recall Observatory FDA recall evidence

Drug product

del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

D-1560-2014

May 28, 2014

Class I

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 68532
Status
Terminated
Classification
Class I
Quantity
31 doses
Official record key
drug-enforcement:D-1560-2014

Official wording

Reason: Non Sterility; microbial contamination identified as Aspergillus species

Code information: Lot# 13-920742-0-1 EXP 21 JUN 2014 and Lot# 13-920452-0-1 through 13-920452-0-30, EXP 21 JUN 2014

Distribution pattern: Michigan and Wisconsin

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    microbial contamination