Drug & medication recalls Moderate risk

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 GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Recall number
D-1203-2022
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

GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

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