D-1218-2022 Class II Ongoing
FDA drug recall D-1218-2022 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: 464 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 20, 2022
- Initiation Date
- Mar 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 464 vials
Product Description
Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1218-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026