Drug product
HCG 1,000 IU/ml + Methylcobalamin 0.05 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
D-1505-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3120 ml total volume
- Official record key
drug-enforcement:D-1505-2015
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; 04152015@15, 6/14/2015; 03232015@64, 5/22/2015; 04222015@68, 6/21/2015; 04272015@86, 6/26/2015; 04292015@62, 6/28/2015; 05062015@5, 7/5/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility