Drug product
S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RX
D-0229-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2x30 ml glass vials
- Official record key
drug-enforcement:D-0229-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S05082019DT@02, Exp 8/8/19; S05112019DH@17, Exp 8/11/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility