Drug product
HCG 1,000 IU/ml + Methylcobalamin 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
D-1506-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 398 ml total volume
- Official record key
drug-enforcement:D-1506-2015
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@3, 6/16/2015; 03242015@49, 5/23/2015; 03272015@31, 5/26/2015; 05052015@51, 7/4/2015; 03252015@2, 5/24/2015; 03252015@30, 5/24/2015; 03302015@45, 5/29/2015; 04162015@26, 6/15/2015; 04212015@7, 6/20/2015; 04172015@71, 6/16/2015; 04292015@53, 6/28/2015; 04072015@53, 6/6/2015; 04272015@44, 6/26/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility