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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-1042-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
1,197 syringes
Official record key
drug-enforcement:D-1042-2023

Official wording

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

Code information: Lot: 17-271144, Exp. 7/25/2023; 17-271354, Exp. 7/27/2023; 17-271681, Exp. 8/2/2023; 17-271990, Exp. 8/7/2023; 17-272457, Exp. 8/16/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility