Drug product
Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made Compounding
D-1205-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 40 vials
- Official record key
drug-enforcement:D-1205-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch #: 12062113A2, Exp 3/6/2022; 01052209B, Exp 4/5/2022; 01312223A1, Exp 5/1/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility