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Recall Observatory FDA recall evidence

Drug product

Testosterone Enanthate 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

D-1647-2015

June 02, 2015

Class II

Product summary

Firm
The Compounding Pharmacy of America
Event
Event 71371
Status
Terminated
Classification
Class II
Quantity
120 ml
Official record key
drug-enforcement:D-1647-2015

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; 12022014@35, 5/31/2015; 01122015@40, 7/11/2015; 12312014@28, 6/29/2015; 03022015@71, 8/29/2015; 03122015@1, 9/8/2015; 04222015@2, 10/19/2015; 04282015@48, 10/25/2015

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