FDA Drug recall D-1218-2022
Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
- FDA Drug
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding by Tmc Acquisition, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1218-2022 |
| 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
Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Batch #: a)11032122A2, Exp 4/30/2022; 01142226A1, Exp 7/13/2022; b)10272101A1, Exp 4/25/2022; 11292137A1, Exp 5/28/2022…Batch #: a)11032122A2, Exp 4/30/2022; 01142226A1, Exp 7/13/2022; b)10272101A1, Exp 4/25/2022; 11292137A1, Exp 5/28/2022; 12142120A2, Exp 6/12/2022; 01042235B, Exp 7/3/2022; 01142226A1, Exp 7/13/2022; 03012240A1, Exp 8/28/2022; 03042223A1, Exp 8/31/2022. |
|---|
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-1218-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.