Drug product
LIPO-VITE Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
D-1688-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2804 ml
- Official record key
drug-enforcement:D-1688-2015
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; 03022015@27, 5/31/2015; 02242015@4, 5/25/2015; 02272015@4, 5/28/2015; 03052015@1, 6/3/2015; 03132015@49, 6/11/2015; 03162015@29, 6/14/2015; 03182015@1, 6/16/2015; 03172015@13, 6/15/2015; 03172015@17, 6/15/2015; 03172015@20, 6/15/2015; 03182015@18, 6/16/2015; 03232015@14, 6/21/2015; 04272015@57, 7/26/2015; 03302015@31, 6/28/2015; 04092015@24, 7/8/2015; 03312015@46, 6/29/2015; 03312015@55, 6/29/2015; 04022015@61, 7/1/2015; 04032015@17, 7/2/2015; 04072015@11, 7/6/2015; 04072015@11, 7/6/2015; 04102015@51, 7/9/2015; 04142015@69, 7/13/2015; 04142015@83, 7/13/2015; 04212015@6, 7/20/2015; 05052015@95, 8/3/2015; 04222015@50, 7/21/2015; 05042015@26, 8/2/2015; 04292015@5, 7/28/2015; 04272015@50, 7/26/2015; 04302015@37, 7/29/2015; 05012015@39, 7/30/2015; 05112015@24, 8/9/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility