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Recall Observatory FDA recall evidence

Drug product

vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1

D-0968-2023

July 14, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92707
Status
Terminated
Classification
Class II
Quantity
2,914 bags
Official record key
drug-enforcement:D-0968-2023

Official wording

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Code information: Lot: 36-239516, 36-239517, Exp. 7/12/2023; 36-239989, Exp. 7/13/2023; 36-240798, Exp. 7/17/2023; 36-241133, Exp. 7/19/2023; 36-241981, Exp. 7/24/2023; 36-242717, Exp. 7/26/2023; 36-245577, Exp. 8/2/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility