FDA Drug Moderate Class II Ongoing

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

Reported: July 20, 2022 Initiated: March 7, 2022 #D-1213-2022

Product Description

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm: TMC Acquisition LLC dba Tailor Made Compounding
Units Affected: 924 vials
Distribution: Nationwide USA and Puerto Rico
Location: Nicholasville, KY

Frequently Asked Questions

What product 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. Recalled by TMC Acquisition LLC dba Tailor Made Compounding. Units affected: 924 vials.

Why was this product recalled? ▼

Lack of Assurance of Sterility

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on July 20, 2022. Severity: Moderate. Recall number: D-1213-2022.