Drug product
S-GLUTATHIONE 200MG/ML MDV, packaged in a) 12 ML b) 30 ml, glass vial, Red Mountain Compounding RX
D-0224-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2x12 ML and 79x30 ML vials
- Official record key
drug-enforcement:D-0224-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: a) S06252019DH@12, Exp 9/25/19; S07162019DT@02, Exp 10/16/19; b) S05162019DH@19, Exp 8/16/19; S05072019DT@08, Exp 8/7/19; S05082019DT@07, Exp 8/8/19; S05282019DT@08, Exp 8/28/19; S05312019DT@05, Exp 8/31/19; S06182019DH@11, Exp 9/18/19; S06242019DH@09, Exp 9/24/19; S07102019DT@06, Exp 10/10/19; S07162019DT@03, Exp 10/16/19; S07222019DH@10, Exp 10/22/19;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility