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Recall Observatory FDA recall evidence

Drug product

midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1

D-1075-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
621 syringes
Official record key
drug-enforcement:D-1075-2023

Official wording

Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles

Code information: Lot: 17-270666, Exp. 7/18/2023; 17-270879, Exp. 7/20/2023; 17-271669, Exp. 8/2/2023; 17-272287, Exp. 8/14/2023; 17-272366, Exp. 8/15/2023; 17-272991, Exp. 8/24/2023; 17-273512, Exp. 9/4/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility