Drug product
Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding
D-1195-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 657 vials
- Official record key
drug-enforcement:D-1195-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch #: a) 02282223A1, Exp 8/27/2022; 10112101A2, Exp 4/9/2022; 11032108A1, Exp 4/30/2022; 11222101A2, Exp 5/21/2022; b) 01042234B, Exp 7/3/2022; 01242211A2, Exp 7/23/2022; 02282222A1, Exp 8/27/2022; 10112101A2, Exp 4/9/2022; 10182101A1, Exp 4/16/2022; 11162112A1, Exp 5/15/2022; 12062105A2, Exp 6/4/2022; 12142143A2, Exp 6/12/2022; 12202102A2, Exp 6/18/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility