Itraconazole 1% eye ointment recall: Sterility Concern
Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Why was Itraconazole 1% eye ointment recalled?
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number CABDCBAC:71, Exp date: 3/23/2013 and Lot number CABDCGAC:35, Exp date: 3/28/2013.
- Product
- Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Recalling firm
- Clinical Specialties Compounding Pharmacy
- Quantity
- 10ml total
- Distribution
- FL, GA and SC.
- Recall date
- July 10, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)