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Recall Observatory FDA recall evidence

Drug product

fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5

D-0013-2024

September 21, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 93103
Status
Terminated
Classification
Class II
Quantity
1,792 bags
Official record key
drug-enforcement:D-0013-2024

Official wording

Reason: Lack of assurance of sterility:

Code information: Lot: 17-275164, exp. 10/1/2023; 17-275623, 17-275631, 17-275640, 17-275649,17-275650, 17-275655, 17-275660, Exp. 10/8/2023; 17-275712, 17-275713, 17-275721, 17-275723, 17-275727, Exp. 10/9/2023; 17-276232, Exp. 10/19/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility