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Recall Observatory FDA recall evidence

Drug product

vancomycin 1.75g added to 0.9% sodium chloride 500mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7060-1

D-0969-2023

July 14, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services, Inc.
Event
Event 92707
Status
Terminated
Classification
Class II
Quantity
6,782 bags
Official record key
drug-enforcement:D-0969-2023

Official wording

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

Code information: Lot: 36-239519, 36-239518, Exp. 7/12/2023; 36-239992, Exp. 7/13/2023; 36-240844, Exp. 7/18/2023; 36-241983, Exp. 7/24/2023; 36-243151, Exp. 7/27/2023; 36-243950, Exp. 7/31/2023; 36-245538, 36-245544, Exp. 8/2/2023; 36-247881, Exp. 8/10/2023; 36-251053, Exp. 8/24/2023; 36-251707, 36-251714, Exp. 8/29/2023; 36-255496, 36-255497, 36-255498, 36-255499, Exp. 9/7/2023; 36-256320, 36-256322, Exp. 9/12/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility