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Recall Observatory FDA recall evidence

Drug product

morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2040-1

D-1064-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
1,699 syringes
Official record key
drug-enforcement:D-1064-2023

Official wording

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

Code information: Lot: 17-270804, Exp. 7/19/2023; 17-271108, Exp. 7/25/2023; 17-271496, Exp. 7/31/2023; 17-271844, Exp. 8/6/2023; 17-272045, Exp. 8/9/2023; 17-272288, Exp. 8/14/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility