Drug product
Methylene Blue Hypotonic Solution, 10mg/mL, a) 2 mL-vial, b) 10mL-vial, Refrigerate, Tailor Made Compounding
D-1218-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 464 vials
- Official record key
drug-enforcement:D-1218-2022
Official wording
Reason: Lack of Assurance of Sterility
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.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility