D-646-2013 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
- N/A
Product Description
Hydroxyprogesterone 250 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 CABDAIAB:64, Exp date: 4/8/2013; Lot number CABDAEAB:21, Exp date: 4/4/2013; Lot number CABDBIAB:75, Exp date: 4/18/2013; Lot number CABDAEAC:00, Exp date: 5/5/2013 and Lot number CABDJAC:67, Exp date: 5/20/2013.