D-655-2013 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
- 95ml total
Product Description
Methylcobalamin 12.5 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 CABCBJBA:55, Exp date: 4/17/2013; Exp date: Lot number CABDCCAB:52, Exp date: 7/21/2013 and Lot number CABDCGAC:50, Exp date: 8/25/2013.