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Recall Observatory FDA recall evidence

Drug product

HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2

D-1055-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
2,389 syringes
Official record key
drug-enforcement:D-1055-2023

Official wording

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

Code information: Lot: 17-270530, Exp. 7/16/2023; 17-270871, Exp. 7/20/2023; 17-271153, Exp. 7/25/2023; 17-271275, Exp. 7/26/2023; 17-271417, Exp. 7/30/2023; 17-271671, Exp. 8/2/2023; 17-271883, Exp. 8/7/2023; 17-271992, Exp. 8/8/2023; 17-272050, Exp. 8/9/2023; 17-272103, Exp. 8/10/2023; 17-272368, 17-272369, Exp. 8/15/2023; 17-272451, Exp. 8/16/2023; 17-273172, Exp. 8/29/2023; 17-273782, Exp. 9/7/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility