Drug product
HCG 500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
D-1533-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 ml total
- Official record key
drug-enforcement:D-1533-2015
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; 04092015@59, 6/8/2015; 04162015@28, 6/15/2015; 03272015@2, 5/26/2015; 03302015@34, 5/29/2015; 04062015@71, 6/5/2015; 04162015@54, 6/15/2015; 05012015@36, 6/30/2015; 05112015@5, 7/10/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility