D-1213-2022 Class II Ongoing

Recalled by TMC Acquisition LLC dba Tailor Made Compounding — Nicholasville, KY

Recall Details

Product Type
Drugs
Report Date
July 20, 2022
Initiation Date
March 7, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
924 vials

Product Description

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

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide USA and Puerto Rico

Code Information

Batch#: a) 01172233A1, Exp 4/17/2022; 01282213A1, Exp 4/28/2022; 02192221A1, Exp 5/20/2022; b)12032118A2, Exp 3/3/2022; 12282120A2, Exp 3/28/2022 01172233A1, Exp 4/17/2022, 01282213A1, Exp 4/28/2022, 02212242A1, Exp 5/22/2022, 03042202A1, Exp 6/2/2022; c) 02192219A1, Exp 5/20/2022; 03062201A1, Exp 6/4/2022.