FDAFDA · Food and drugs·Recall number D-1569-2015
Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, 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; 03022015@86, 5/31/2015; 04012015@71, 6/30/2015; 02202015@43, 5/21/2015,; 2232015@74, 5/24/2015; 02272015@70, 5/28/2015; 03052015@8, 6/3/2015; 03102015@61, 6/8/2015; 03092015@97, 6/7/2015; 03202015@98, 6/18/2015; 03232015@62, 6/21/2015; 03272015@50, 6/25/2015; 03312015@47, 6/29/2015; 04022015@20, 7/1/2015; 04062015@1, 7/5/2015; 04062015@61, 7/5/2015; 04132015@49, 7/12/2015; 04132015@53, 7/12/2015; 04152015@26, 7/14/2015; 04162015@20, 7/15/2015; 04222015@41, 7/21/2015; 04162015@50, 7/15/2015; 05012015@52, 7/30/2015; 04242015@64, 7/1/2015; 04302015@3, 7/29/2015; 04302015@40, 7/29/2015; 04302015@43, 7/29/2015; 04292015@99, 7/28/2015; 05062015@19, 8/4/2015; 05122015@14, 7/11/2015
- 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.