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Recall Observatory FDA recall evidence

Drug product

Testosterone 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

D-1742-2015

June 02, 2015

Class II

Product summary

Firm
The Compounding Pharmacy of America
Event
Event 71371
Status
Terminated
Classification
Class II
Quantity
1222 pellets
Official record key
drug-enforcement:D-1742-2015

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; 01082015@1, 7/7/2015; 11212014@6, 5/20/2015; 11212014@8, 5/20/2015; 1242014@51, 5/23/2015, 11262014@72, 5/25/2015, 01152015@29, 7/14/2015; 02112015@12, 8/10/2015; 12192014@6, 6/17/2015; 12012014@57, 5/30/2015; 12022014@33; 5/31/2015; 12042014@50, 6/2/2015; 12152014@10, 6/13/2015; 12082014@38; 6/6/2015; 12182014@18, 6/16/2015; 12092014@62, 6/7/2015; 12292014@37, 6/27/2015; 12292014@72, 6/29/2015; 01222015@44, 7/21/2015; 01052015@3, 7/4/2015; 01092015@9, 7/8/2015; 01202015@42; 7/19/2015; 04212015@11, 10/18/2015; 01272015@40, 7/26/2015; 01292015@25, 7/28/2015; 01282015@30, 7/27/2015; 02102015@34, 8/9/2015; 02092015@29, 8/8/2015; 02132015@26, 8/12/2015; 02232015@10, 8/22/2015; 02242015@13, 8/23/2015; 02162015@28, 8/15/2015; 04102015@38, 10/7/2015; 05042015@34, 10/31/2015; 02272015@29, 8/26/2015, 03032015@16, 8/30/2015, 03112015@34, 9/7/2015; 03182015@26, 9/14/2015; 03272015@29; 9/23/2015; 04012015@5, 9/28/2015, 04062015@16, 10/3/2015; 04032015@57, 9/30/2015; 04212015@42; 10/18/2015; 05012015@6, 10/28/2015; 05072015@57, 11/3/2015; 05042015@13, 10/31/2015; 04272015@39, 10/24/2015, 04282015@60, 10/25/2015; 05062015@14, 11/2/2015; 05112015@28, 11/7/2015

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