FDAFDA · Food and drugs·Recall number D-1743-2015
Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Published September 23, 2015 · Recall initiated: June 2, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- The Compounding Pharmacy of America
- Distributor
- Nationwide
- Lot
- All lots distributed between November 2014 and May 2015; 11262014@67, 5/25/2015; 03022015@70, 8/29/2015; 01052015@50, 7/4/2015; 02052015@72, 8/4/2015; 04302015@53, 10/27/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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