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Recall Observatory FDA recall evidence

Drug product

oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1

D-1133-2023

August 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92898
Status
Terminated
Classification
Class II
Quantity
2643 bags
Official record key
drug-enforcement:D-1133-2023

Official wording

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

Code information: Lot# 36-260031, 36-260027, Exp 10/3/2023; 36-262533,36-262532, 36-262531, 36-262530, 36-262529, 36-262528, 36-262527, Exp 10/9/2023. ;

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility