D-1214-2022 Class II Ongoing
FDA drug recall D-1214-2022 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: 232 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 20, 2022
- Initiation Date
- Mar 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 232 vials
Product Description
Methionine/Inositol/Choline B12 25mg/50mg/50mg/1mg/mL, a)10 mL-vial, b) 30 mL-vial, Room Temperature, Tailor Made Compounding
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Batch#: a) 12092105A2, exp 3/9/2022; 01042219A2, Exp 4/4/2022; 01202210A2, exp 4/20/2022; 01282207A1, exp 4/28/2022; 03032217A1, Exp 6/1/2022; 12092105A2; b) 01282207A1, Exp 4/28/2022; 03032241A1, 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-1214-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026