Drug product
S-GLUTATHIONE 200MG/3ML (PF) INHALATION SOLN, 3ML Prefilled Syringe, Red Mountain Compounding RX
D-0223-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1, 3 ml prefilled syringe
- Official record key
drug-enforcement:D-0223-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S07262019DH@02, Exp 8/26/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility