FDA Drug recall D-1216-2022
Methylcobalamin 1mg/mL, a) 10 mL-vial, b) 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 1mg/mL, a) 10 mL-vial, b) 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-1216-2022 |
| 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 1mg/mL, a) 10 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Batch #: a) 10282106A1, Exp 4/26/2022; 11022118A1, Exp 4/30/2022; 12292115A1, Exp 6/27/2022; b)12082113A2, Exp 6/2/2022…Batch #: a) 10282106A1, Exp 4/26/2022; 11022118A1, Exp 4/30/2022; 12292115A1, Exp 6/27/2022; b)12082113A2, Exp 6/2/2022; 12292115A1, Exp 6/27/2022; 03072230A1, Exp 9/3/2022. |
|---|
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-1216-2022%22
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