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Recall Observatory FDA recall evidence

Drug product

ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-3022-1

D-1071-2023

July 17, 2023

Class II

Product summary

Firm
Central Admixture Pharmacy Services Inc
Event
Event 92752
Status
Terminated
Classification
Class II
Quantity
2,994 syringes
Official record key
drug-enforcement:D-1071-2023

Official wording

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

Code information: Lot: 17-274122, 17-274147, 17-274155, 17-274158, 17-274162, Exp. 9/13/2023

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility