Drug product
LIPO-VITE III, Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
D-1689-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 620 ml
- Official record key
drug-enforcement:D-1689-2015
Official wording
Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Code information: All lots distributed between November 2014 and May 2015; 02232015@72, 5/24/2015; 02252015@60, 5/26/2015; 03112015@55, 6/9/2015; 03122015@99, 6/10/2015; 03172015@67, 6/15/2015; 03312015@74, 6/29/2015; 05052015@34, 8/3/2015; 04292015@21, 7/28/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility