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FDAFDA · Food and drugs·Recall number D-1746-2015

Testosterone 25 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; 12102014@3, 6/8/2015; 12042014@62, 6/2/2015; 01192015@15, 7/18/2015; 01062015@12, 7/5/2015; 02202015@23, 8/19/2015; 02242015@35, 8/23/2015; 03032015@17, 8/30/2015; 03252015@9, 9/21/2015; 04292015@19, 10/26/2015
Risk classification
Class II
Area (FDA)
drug
Country
United States

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