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07-10-2013, 04:01 PM #1
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Recall: Itraconazole 1% eye ointment
Product Detail
Product Description Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Recall Number D-648-2013
Classification Class II
Code Info Lot number CABDCBAC:71, Exp date: 3/23/2013 and Lot number
CABDCGAC:35, Exp date: 3/28/2013.
Product Distributed Qty 10ml 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.
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