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Recall Observatory FDA recall evidence

Drug product

fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1

D-0019-2024

September 21, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 93103
Status
Terminated
Classification
Class II
Quantity
50, 3 mL syringes
Official record key
drug-enforcement:D-0019-2024

Official wording

Reason: Lack of assurance of sterility:

Code information: Lot: 17-275284, Exp. 10/3/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility