D-674-2013 Class II Terminated
FDA drug recall D-674-2013 was initiated by Clinical Specialties Compounding Pharmacy on March 20, 2013 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes The recall status is terminated (terminated February 22, 2017). Affected quantity: 65ml total.
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
- 65ml total
Product Description
Test Cyp 50 mg-estradiol cyp 2 mg/ml, 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 CABCACBB:31, Exp date: 10/28/2013 and Lot number CABDBGAB:74, Exp date: 1/11/2014.