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Recall Observatory FDA recall evidence

Drug product

oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1

D-1132-2023

August 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92898
Status
Terminated
Classification
Class II
Quantity
1,996 bags.
Official record key
drug-enforcement:D-1132-2023

Official wording

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

Code information: Lot# 36-260043, 36-260039, Exp 9/8/2023; 36-262220, Exp 9/10/2023; 36-262526, 36-262525, 36-262524, Exp 9/14/2023. ;

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility