D-1688-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 23, 2015
- Initiation Date
- June 2, 2015
- Termination Date
- February 10, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2804 ml
Product Description
LIPO-VITE Injection, Multi-Dose Vial, Sterile, Room Temperature, 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 Pattern
Nationwide
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