FDAFDA · Food and drugs·Recall number D-1616-2015
Nandrolone Decanoate 200 mg/ml Injection, 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: 02272015@1, 8/26/2015; 12182015@67, 6/16/2015; 02062015@141, 8/5/2015; 04222015@13, 9/29/2015; 04072015@33, 10/4/2015; 04212015@13, 10/18/2015; 04082015@7, 10/5/2015 ; 04142015@24, 10/11/2015; 04272015@84, 10/24/2015; and 05082015@7, 11/4/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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