Drug product
Estradiol Cypionate 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
D-639-2013
Product summary
- Event
- Event 64661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 95 ml total
- Official record key
drug-enforcement:D-639-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Code information: Lot number CABCACBA:20, Exp date: 3/31/2013; Lot number CABCABBB:22, Exp date: 4/30/2013; Lot number CABCBJBB:25, Exp date: 5/18/2013 and Lot number CABDAFAC:79, Exp date: 8/4/2013.
Distribution pattern: FL, GA and SC.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility