Drug product
Estradiol Valerate 30 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
D-641-2013
Product summary
- Event
- Event 64661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18ml total
- Official record key
drug-enforcement:D-641-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Code information: Lot number CABCBFBB:12, Exp date: 5/14/2013 and Lot number CABDAIAD:28, Exp date: 9/4/2013.
Distribution pattern: FL, GA and SC.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility