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Recall Observatory FDA recall evidence

Drug product

fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2001-2

D-0024-2024

September 21, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 93103
Status
Terminated
Classification
Class II
Quantity
962 30 mL syringes.
Official record key
drug-enforcement:D-0024-2024

Official wording

Reason: Lack of assurance of sterility:

Code information: Lot:17-275321, Exp. 10/3/2023; 17-275779, 17-275790, Exp. 10/10/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility