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Recall Observatory FDA recall evidence

Drug product

fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2

D-1053-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
1669 syringes
Official record key
drug-enforcement:D-1053-2023

Official wording

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

Code information: Lot: 17-270685, Exp. 7/18/2023; 17-271343, Exp. 7/27/2023; 17-271490, Exp. 7/31/2023; 17-271578, Exp. 8/1/2023; 17-272293, Exp. 8/14/2023; 17-272786, Exp. 8/22/2023; 17-273575, Exp. 9/5/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility