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Recall Observatory FDA recall evidence

Drug product

fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2071-1

D-1079-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
6,770 syringes
Official record key
drug-enforcement:D-1079-2023

Official wording

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

Code information: Lot: 17-270539, Exp. 7/16/2023; 17-270981, Exp. 7/23/2023; 17-271167, Exp. 7/25/2023; 17-271337, Exp. 7/27/2023; 17-271827, Exp. 8/6/2023; 17-272214, Exp. 8/13/2023; 17-272536, 17-272555, Exp. 8/17/2023; 17-273424, 17-273432, Exp. 9/3/2023; 17-273476, Exp. 9/4/2023; 17-273882, Exp. 9/10/2023; 17-274044, Exp. 9/12/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility