Drug product
HCG 2,500 IU/ml + Methylcobalamin 500 mcg/ml, Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
D-1511-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 61 ml total
- Official record key
drug-enforcement:D-1511-2015
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; 03242015@5, 5/23/2015; 05042015@78, 7/3/2015; 03262015@2, 5/25/2015; 04062015@52, 6/5/2015; 04242015@58, 6/23/2015; 05072015@17, 7/6/2015; 05082015@19, 7/7/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility