Status
Terminated
Drug Enforcement D-648-2013
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Classification
Class II
Report Date
July 10, 2013
Termination Date
February 22, 2017
Product Information
- Product description
- Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Product quantity
- 10ml total
- Reason for recall
- Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- FL, GA and SC.
Location & Firm
- Recalling firm
- Clinical Specialties Compounding Pharmacy
- Address
-
318 Baston Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-648-2013
- Event ID
- 64661
- Recall initiation date
- March 20, 2013
- Center classification date
- July 3, 2013
- Code info
- Lot number CABDCBAC:71, Exp date: 3/23/2013 and Lot number CABDCGAC:35, Exp date: 3/28/2013.
- More code info
- —