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Recall Observatory FDA recall evidence

Drug product

morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2041-2

D-1068-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
723 syringes
Official record key
drug-enforcement:D-1068-2023

Official wording

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

Code information: Lot: 17-271060, Exp. 7/24/2023; 17-271252, Exp. 7/26/2023; 17-271571, Exp. 8/1/2023; 17-272471, Exp. 8/16/2023; 17-272785, Exp. 8/22/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility