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Recall Observatory FDA recall evidence

Drug product

fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1

D-1069-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
295 bags
Official record key
drug-enforcement:D-1069-2023

Official wording

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

Code information: Lot: 17-271814, Exp. 8/6/2023; 17-271960, Exp. 8/8/2023; 17-272252, Exp. 8/13/2023; 17-272272, Exp. 8/14/2023; 17-272454, Exp. 8/16/2023; 17-272640, Exp. 8/20/2023; 17-272716, Exp. 8/21/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility