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Recall Observatory FDA recall evidence

Drug product

KETAMINE 10 MG/ML INJ SOL SYR (C-III), [a) 2 ML NDC: 70731-0132-02; b) 5 ML NDC: 70731-0132-05] per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701.

D-1670-2019

June 19, 2019

Class II

Product summary

Firm
RXQ Compounding LLC
Event
Event 83074
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1670-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: All lots within expiry

Distribution pattern: Nationwide USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility