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Recall Observatory FDA recall evidence

Drug product

morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2040-4

D-1080-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
1,235 syringes
Official record key
drug-enforcement:D-1080-2023

Official wording

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

Code information: Lot: 17-273353, Exp 8/31/2023, 17-270602, Exp 7/17/2023; 17-270706, Exp 7/18/2023; 17-271416, Exp 7/30/2023; 17-272049, Exp 8/9/2023; 17-272277, Exp 8/14/2023; 17-273231, Exp 8/30/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility