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Recall Observatory FDA recall evidence

Drug product

Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.

D-1105-2023

August 15, 2023

Class II

Product summary

Firm
TMC Acquisitions LLC dba Tailor Made Compounding
Event
Event 92896
Status
Terminated
Classification
Class II
Quantity
9 vials
Official record key
drug-enforcement:D-1105-2023

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot#: 07262326A1, BUD: 10/24/2023

Distribution pattern: Nationwide within the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility