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Recall Observatory FDA recall evidence

Drug product

LIPOLEAN Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1733-2015

June 02, 2015

Class II

Product summary

Firm
The Compounding Pharmacy of America
Event
Event 71371
Status
Terminated
Classification
Class II
Quantity
1830 ml
Official record key
drug-enforcement:D-1733-2015

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; 05082015@29, 8/6/2015; 04022015@43, 7/1/2015; 04242015@32, 7/23/2015; 04282015@37, 7/27/2015; 04292015@97, 7/28/2015; 04302015@61, 7/29/2015

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