Drug product
HCG 2,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
D-1528-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 99 ml total
- Official record key
drug-enforcement:D-1528-2015
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; 03312015@18, 5/30/2015; 03252015@49, 5/24/2015; 04012015@60 5/31/2015; 05112015@59, 7/10/2015; 04062015@39, 6/5/2015; 04072015@25, 6/6/2015; 04072015@74, 6/6/2015; 04142015@44, 6/13/2015; 04172015@72, 6/16/2015; 04172015@77, 6/16/2015; 04232015@8, 6/22/2015; 04222015@60, 6/21/2015; 04242015@11, 6/23/2015; 04292015@33, 6/28/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility