Results 1 to 1 of 1
07-10-2013, 02:54 PM #1
- Join Date
- Aug 2012
- Merced, CA 95348-1422
- Blog Entries
Recall: Cyclosporine 2% ophthalmic
Product Description Cyclosporine 2% ophthalmic, Clinical Specialties
Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Recall Number D-637-2013
Classification Class II
Code Info Lot number CABCCIBC:89, Exp date: 3/28/2013; Lot number CABDBEAB:07, Exp date: 4/14/2013; Lot number CABDCIAB:42, Exp date: 4/28/2013 and Lot number CABDCCAC:37, Exp date: 5/23/2013.
Product Distributed Qty 87 ml total
Reason For Recall Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Event Id 64661
Product Type Drugs
Clinical Specialties Compounding Pharmacy
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-20
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern FL, GA and SC.