Drug product
Glutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding
D-1243-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 485 Vials
- Official record key
drug-enforcement:D-1243-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: a) 01122204A1, Exp 4/12/2022; 02192214A1, Exp 5/20/2022; b) 12142122A2, Exp. 3/14/2022; 12282118A2, Exp 3/28/2022; 01112203A1, Exp 4/11/2022; 01122208A1, Exp 4/12/2022; 01202211A2, Exp 4/20/2022; 02032205A1, Exp 5/4/2022; 02192212A1, Exp 5/20/2022; 03042201A1, Exp 6/2/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility