D-677-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 10, 2013
- Initiation Date
- March 20, 2013
- Termination Date
- February 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13ml total
Product Description
Test Cyp 50 mg-estradiol blend 22 mg, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Reason for Recall
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Distribution Pattern
FL, GA and SC.
Code Information
Lot number CABCAIBA:36, Exp date: 4/6/2013; Lot number CABDDAAB:10, Exp date: 7/29/2013 and Lot number CABDAIAD:01 Exp date: 9/4/2013.