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Recall Observatory FDA recall evidence

Drug product

Testosterone 200 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1745-2015

June 02, 2015

Class II

Product summary

Firm
The Compounding Pharmacy of America
Event
Event 71371
Status
Terminated
Classification
Class II
Quantity
510 pellets
Official record key
drug-enforcement:D-1745-2015

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; 12122014@8, 6/10/2015; 12042014@47, 6/2/2015; 01122015@54, 7/11/2015; 04142015@82, 10/11/2015; 01072015@32, 7/6/2015; 01192015@17, 7/18/2015; 02042015@43, 8/3/2015; 02232015@35, 8/22/2015; 02272015@30, 8/26/2015; 02272015@19, 8/26/2015; 03162015@55, 9/12/2015; 03192015@23, 9/15/2015; 03192015@33, 9/15/2015; 04012015@55, 9/28/2015; 04072015@42, 10/4/2015, 04072015@6, 10/4/2015; 04102015@46, 10/7/2015; 04162015@56, 10/13/2015; 04282015@7, 10/25/2015, 04272015@59, 10/24/2015; 04302015@59, 10/27/2015

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