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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 71286-2071-7

D-0001-2024

September 21, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 93103
Status
Terminated
Classification
Class II
Quantity
1,762 Syringes
Official record key
drug-enforcement:D-0001-2024

Official wording

Reason: Lack of assurance of sterility:

Code information: Lot: 17-275858, Exp. 10/11/2023; 17-275967, 17-275981, Exp. 10/15/2023

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility