D-663-2013 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
- 116ml total
Product Description
Sodium Chloride (23.4%), 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 CABCCEAJ:09, Exp date: 3/23/2013; Lot number CABCBFBA:92, Exp date: 4/13/2013; Lot number CABDAGAC:58, Exp date: 8/5/2013 and Lot number CABDAEAD:01, Exp date: 8/31/2013.