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Recall Observatory FDA recall evidence

Drug product

fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3

D-1047-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
1,216 syringes
Official record key
drug-enforcement:D-1047-2023

Official wording

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

Code information: Lot: 17-270771, Exp. 7/19/2023; 17-271134, Exp. 7/25/2023; 17-271577, Exp. 8/1/2023; 17-271745, Exp. 8/3/2023; 17-272026, Exp. 8/9/2023; 17-272345, Exp. 8/15/2023; 17-272615, Exp. 8/20/2023; 17-273668, Exp. 9/6/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility