D-1211-2022 Class II Ongoing

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

FDA drug recall D-1211-2022 was initiated by TMC Acquisition LLC Dba Tailor Made Compounding on Mar 7, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 12 vials.

Recall Details

Product Type
Drugs
Report Date
Jul 20, 2022
Initiation Date
Mar 7, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 vials

Product Description

Levocarnitine 500mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide USA and Puerto Rico

Code Information

Batch #: 12022124A2, Exp 3/2/2022; 03032223A1, Exp 6/1/2022.

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-1211-2022
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.