Skip to content
Recall Observatory FDA recall evidence

Drug product

LIPO-VITE III, Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1689-2015

June 02, 2015

Class II

Product summary

Firm
The Compounding Pharmacy of America
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

    reason.manufacturing_process_control · v1.0.0

    GMP violations
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility