Itraconazole 1% Eye Ointment Recalled Due to Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling Itraconazole 1% eye ointment because FDA inspections raised concerns about quality control and sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of sterility failure in an ophthalmic product.
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling Itraconazole 1% eye ointment. The recall was initiated following FDA inspection findings that resulted in concerns regarding the quality control processes and the assurance of sterility for the product.
The affected product is Itraconazole 1% eye ointment, 10ml total, manufactured by Clinical Specialties Compounding Pharmacy located at 318 Baston Road, Augusta, GA 30907. The recall covers two specific lots: Lot number CABDCBAC:71 with an expiration date of 3/23/2013, and Lot number CABDCGAC:35 with an expiration date of 3/28/2013.
The product was distributed in Florida, Georgia, and South Carolina. Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Ophthalmic
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot number CABDCBAC:71
- Exp date: 3/23/2013 and Lot number CABDCGAC:35
- Exp date: 3/28/2013.
Distribution
Part of a larger recall action
This product is one of 49 recalled by Clinical Specialties Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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