Drug product
S-HYDROCHLORIC ACID 2MG/ML INJ SOLN, 50 ML glass vial, Red Mountain Compounding RX
D-0228-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0228-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S06092019DH@03, Exp 9/9/19; S06162019DH@17, Exp 9/16/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility