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Recall Observatory FDA recall evidence

Drug product

fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4

D-1050-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
848 bags
Official record key
drug-enforcement:D-1050-2023

Official wording

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

Code information: Lot: 17-270533, Exp. 7/16/2023; 17-270580, 17-270581, Exp. 7/17/2023; 17-270654, Exp. 7/18/2023; 17-271044, Exp. 7/24/2023; 17-271243, Exp. 7/26/2023; 17-271439, Exp. 7/30/2023; 17-271562, Exp. 8/1/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility