Skip to content
Recall Observatory FDA recall evidence

Drug product

vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1

D-0948-2023

July 14, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92707
Status
Terminated
Classification
Class II
Quantity
3,980 bags
Official record key
drug-enforcement:D-0948-2023

Official wording

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

Code information: Lot: 36-245576, Exp. 8/2/2023; 36-254436, 36-254442, Exp. 9/5/2023; 36-255131, Exp. 9/6/2023; 36-256045, Exp. 9/11/2023; 36-239523, Exp. 7/12/2023; 36-248987, Exp. 8/16/2023; 36-240797, Exp. 7/17/2023; 36-241979, Exp. 7/24/2023; 36-242705, Exp. 7/26/2023; 36-251733, 36-251738, 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