FDAFDA · Food and drugs·Recall number D-1528-2015
HCG 2,500 IU/ml Injection, 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; 03312015@18, 5/30/2015; 03252015@49, 5/24/2015; 04012015@60 5/31/2015; 05112015@59, 7/10/2015; 04062015@39, 6/5/2015; 04072015@25, 6/6/2015; 04072015@74, 6/6/2015; 04142015@44, 6/13/2015; 04172015@72, 6/16/2015; 04172015@77, 6/16/2015; 04232015@8, 6/22/2015; 04222015@60, 6/21/2015; 04242015@11, 6/23/2015; 04292015@33, 6/28/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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