D-659-2013 Class II Terminated
FDA drug recall D-659-2013 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: 360ml 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
- 360ml total
Product Description
Ophthalmic dilation gel (MAR), 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 CABDBFAC:88, Exp date: 5/16/2013; and Lot number CABDCBAB:42, Exp date: 4/21/2013.