Product Detail

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 Detail

Event Id 64661

Product Type Drugs

Status Ongoing

Recalling Firm
Clinical Specialties Compounding Pharmacy
City Augusta
State GA
Country US

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.