FDAFDA · Food and drugs·Recall number D-1457-2015
Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, 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 05062015@2, 8/4/2015; 03182015@9, 6/16/2015; 03242015@9, 6/22/2015; 03312015@72, 6/29/2015; 04152015@12, 7/14/2015; 04152015@13, 7/14/2015; 05052015@93, 8/3/2015; 05012015@35, 7/30/2015; 05072015@10, 8/5/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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