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Recall Observatory FDA recall evidence

Drug product

L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692

D-0057-2026

July 30, 2025

Class II

Product summary

Firm
GenoGenix LLC
Event
Event 97369
Status
Ongoing
Classification
Class II
Quantity
161
Official record key
drug-enforcement:D-0057-2026

Official wording

Reason: Lack of Assurance of Sterility

Code information: All lots within expiry.

Distribution pattern: US Nationwide.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility