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Recall Observatory FDA recall evidence

Drug product

Testosterone 87.5 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1751-2015

June 02, 2015

Class II

Product summary

Firm
The Compounding Pharmacy of America
Event
Event 71371
Status
Terminated
Classification
Class II
Quantity
265 pellets
Official record key
drug-enforcement:D-1751-2015

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@60, 8/29/2015; 12042014@65, 6/2/2015; 12182014@39, 6/16/2015; 01152015@37, 7/14/2015; 01052015@1, 7/4/2015; 02052015@50, 8/4/2015; 02132015@14, 8/12/2015; 03162015@14, 9/12/2015; 03252015@14, 9/21/2015; 04222015@44, 10/19/2015, 05042015@28, 10/31/2015

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