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Recall Observatory FDA recall evidence

Drug product

fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2080-2

D-1067-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
1,486 syringes
Official record key
drug-enforcement:D-1067-2023

Official wording

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

Code information: Lot: 17-270811, Exp. 7/19/2023; 17-270954, 17-270983, Exp. 7/23/2023; 17-271231, Exp. 7/26/2023; 17-271690, Exp. 8/2/2023; 17-272204, Exp. 8/13/2023; 17-272684, Exp. 8/20/2023; 17-272992, Exp. 8/24/2023; 17-273053, Exp. 8/28/2023; 17-273436, Exp. 9/3/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility