FDAFDA · Food and drugs·Recall number D-1444-2015
B-Complex Injection, Sterile, Refrigerate, 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; 02192015@21, 5/20/2015; 03032015@3, 6/1/2015; 02242015@37, 5/25/2015; 03122015@27, 6/10/2015; 03182015@48, 6/16/2015; 03272015@14, 6/25/2015; 04072015@16, 7/6/2015, 04072015@18, 7/6/2015, 04202015@80, 7/19/2015, 04222015@85, 7/21/2015; 05072015@25, 8/5/2015; 04272015@74, 7/26/2015; 04272015@81, 7/26/2015; 04292015@98, 7/28/2015; 05012015@17, 7/30/2015; 05042015@45, 8/2/2015; 02202015@47, 5/21/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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