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Recall Observatory FDA recall evidence

Drug product

vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1

D-0950-2023

July 14, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92707
Status
Terminated
Classification
Class II
Quantity
4824 bags
Official record key
drug-enforcement:D-0950-2023

Official wording

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

Code information: Lot: 36-245562, Exp. 8/2/2023; 36-254425, Exp. 9/5/2023; 36-255129, Exp. 9/6/2023; 36-238965, Exp. 7/10/2023; 36-256041, Exp. 9/11/2023; 36-241129, 36-241130, Exp. 7/19/2023; 36-241438, Exp. 7/20/2023; 36-242703, Exp. 7/26/2023; 36-243163, 36-243164, Exp. 7/27/2023; 36-251724, 36-251727, Exp. 8/29/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility