FDA Drug recall D-1213-2022
Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Refrigerate, Tailor Mad…
- FDA Drug
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Refrigerate, Tailor Mad… by Tmc Acquisition, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1213-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-07 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Tmc Acquisition |
| Distribution | US |
Product
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
Lack of Assurance of Sterility
Identifiers
| code_info | Batch#: a) 01172233A1, Exp 4/17/2022; 01282213A1, Exp 4/28/2022; 02192221A1, Exp 5/20/2022; b)12032118A2, Exp 3/3/2022;…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1213-2022%22
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