FDAFDA · Food and drugs·Recall number D-1637-2015
Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free, 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; 03112015@2, 6/9/2015; 03162015@6/14/2015; 03242015@2, 6/22/2015, 03302015@62, 6/28/2015, 0406201@43, 7/5/2015; 04142015@62, 7/13/2015, 04122015@6/20/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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