Drug product
Sermorelin Injection 10mg/10mL,10mg/mL, 20mg/10mL, 9mg/9mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
D-0450-2016
Product summary
- Firm
- Western Drug
- Event
- Event 72520
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45 containers
- Official record key
drug-enforcement:D-0450-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: all lots
Distribution pattern: Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility