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Recall Observatory FDA recall evidence

Drug product

Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding

D-1197-2022

March 07, 2022

Class II

Product summary

Firm
TMC Acquisition LLC dba Tailor Made Compounding
Event
Event 89909
Status
Ongoing
Classification
Class II
Quantity
39
Official record key
drug-enforcement:D-1197-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: Batch #: 12032113A2, Exp 6/1/2022; 01102206A1, Exp 7/9/2022.

Distribution pattern: Nationwide USA and Puerto Rico

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility