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Recall Observatory FDA recall evidence

Drug product

fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-1

D-1070-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
1,114 bags
Official record key
drug-enforcement:D-1070-2023

Official wording

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

Code information: Lot: 17-274485, Exp. 9/19/2023; 17-270783, Exp. 7/19/2023; 17-270882, Exp. 7/20/2023; 17-271430, Exp. 7/30/2023; 17-271509, Exp. 7/31/2023; 17-272224, 17-272238, Exp. 8/13/2023; 17-272704, Exp. 8/21/2023; 17-273147, Exp. 8/29/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility