FDA Drug recall D-1215-2022
Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temperature, Tailor Made Compounding
- FDA Drug
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temperature, Tailor Made Compounding by Tmc Acquisition, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1215-2022 |
| 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
Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temperature, Tailor Made Compounding
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Batch#: a)11092114A2, Exp 4/30/2022; 12172113A2, Exp 6/15/2022; 03072227A1, Exp 9/3/2022; b)10122101A2, Exp 4/10/2022;…Batch#: a)11092114A2, Exp 4/30/2022; 12172113A2, Exp 6/15/2022; 03072227A1, Exp 9/3/2022; b)10122101A2, Exp 4/10/2022; 12022116A1, Exp 5/31/2022; 12292115A1, Exp 6/27/2022; 02222207A1, Exp 8/21/2022; c)10112103A2, Exp 4/9/2022; 11192112A2, Exp 5/18/2022; 12142114A2, Exp 6/12/2022; 12202103A1, Exp 6/18/2022; 12282119A2, Exp 6/26/2022; 01192222A1, Exp 7/18/2022; 02232201A1, Exp 8/22/2022. |
|---|
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-1215-2022%22
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