FDAFDA · Food and drugs·Recall number D-1218-2022
Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
Published July 20, 2022 · Recall initiated: March 7, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- TMC Acquisition LLC dba Tailor Made Compounding
- Distributor
- Nationwide USA and Puerto Rico
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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