Status
Terminated
Drug Enforcement D-658-2013
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
- Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Product quantity
- 378ml 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-658-2013
- Event ID
- 64661
- Recall initiation date
- March 20, 2013
- Center classification date
- July 3, 2013
- Code info
- Lot number CABDBDAC:11, Exp date: 8/12/2013; Lot number CABCCHAJ:28, Exp date: 3/26/2013; Lot number CABCBBBA:57, Exp date: 4/9/2013; Lot number CABCCGBA:11, Exp date: 4/24/2013; Lot number CABCACBB:26, Exp date: 5/1/2013; Lot number CABCBGBB:54, Exp date: 5/15/2013; Lot number CABCCJBB:38, Exp date: 5/28/2013; Lot number CABCBDBC:40, Exp date: 6/11/2013; Lot number CABCCIBC:73, Exp date: 6/26/2013; Lot number CABDBBAB:32, Exp date: 7/10/2013; Lot number CABDCEAB:92, Exp date: 7/23/2013; Lot number CABDAHAC:76, Exp date: 8/6/2013; Lot number CABDCBAC:11, Exp date: 8/20/2013 and Lot number CABDAHAD:85, Exp date: 9/3/2013.
- More code info
- —