TMC Acquisition LLC dba Tailor Made Compounding product recalled over sterility concerns
- Recall date
- March 7, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- TMC Acquisition LLC dba Tailor Made Compounding recalls Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Ref…
- Recall number
- D-1213-2022
- FDA classification
- Class II
- Brand / firm
- TMC Acquisition LLC dba Tailor Made Compounding
- Sold / distributed
- Nationwide USA and Puerto Rico
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Refrigerate, Tailor Made Compounding
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