Drug product
HCG 11,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
D-1524-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 112 ml total
- Official record key
drug-enforcement:D-1524-2015
Official wording
Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Code information: All lots distributed between November 2014 and May 2015; 04172015@59, 6/16/2015; 04302015@57, 6/29/2015; 03262015@39, 5/25/2015; 04012015@42, 5/31/2015; 04022015@18, 6/1/2015; 04302015@4, 6/29/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility