Ophthalmic Dilation Gel (Clinical Specialties) – Sterility Concern (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Brand
Clinical Specialties Compounding Pharmacy
Lot Codes / Batch Numbers
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.
Products Sold
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.
Clinical Specialties Compounding Pharmacy is recalling Ophthalmic dilation gel, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 309 due to Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, GA, SC
Page updated: Jan 7, 2026