FDAFDA · Food and drugs·Recall number D-1522-2015
HCG 625 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; 05072015@2, 7/6/2015; 04082015@25, 6/7/2015; 03042015@54, 6/2/2015; 04142015@16, 6/13/2015; 03312015@37, 5/30/2015; 04062015@75, 6/5/2015; 05112015@15, 7/10/2015; 04272015@21, 6/26/2015; 04272015@62, 6/26/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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