Drug product
HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
D-1518-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 695 ml total
- Official record key
drug-enforcement:D-1518-2015
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@6,6/8/2015; 04202015@38, 6/19/2015; 04202015@8, 6/19/2015; 03202015@99, 5/22/2015; 03302015@54, 5/29/2015; 03312015@56, 5/30/2015; 04072015@7, 6/6/2015; 04062015@56, 6/5/2015; 04142015@86, 6/13/2015; 05052015@49, 7/4/2015; 05062015@30, 7/5/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility