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Recall Observatory FDA recall evidence

Drug product

dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1

D-1138-2023

August 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92898
Status
Terminated
Classification
Class II
Quantity
703 bags.
Official record key
drug-enforcement:D-1138-2023

Official wording

Reason: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Code information: Lot# 36-260048, Exp 9/13/2023; 36-262174, Exp 9/15/2023; 36-262523, Exp 9/19/2023. ;

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility