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Recall Observatory FDA recall evidence

Drug product

HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1

D-1044-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
2,717 syringes
Official record key
drug-enforcement:D-1044-2023

Official wording

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

Code information: Lot: 17-270603, Exp. 7/17/2023; 17-270802, Exp. 7/19/2023; 17-271073, Exp. 7/24/2023; 17-271129, Exp. 7/25/2023; 17-271254, Exp. 7/26/2023; 17-271953, Exp. 8/8/2023; 17-272022, Exp. 8/9/2023; 17-272295, Exp. 8/14/2023; 17-272616, Exp. 8/20/2023; 17-273357, Exp. 8/31/2023; 17-273501, Exp. 9/4/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility