FDA recall D-1809-2015
The Compounding Pharmacy of America · Class II · drug
Product
Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable, The Compounding Pharmacy of America, Knoxville, TN
Reason for recall
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2015-06-02
- Report date
- 2015-09-23
- Termination date
- 2016-02-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Knoxville, TN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1809-2015