FDAFDA · Food and drugs·Recall number D-1488-2015
Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal 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; 02252015@14, 5/26/2015; 04012015@2, 6/30/2015; 04272015@30, 7/26/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.