Cyclosporine 1% Ophthalmic Drops Recalled for Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling specific lots of Cyclosporine 1% ophthalmic drops due to FDA inspection findings regarding quality control and lack of assurance of sterility.
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 source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe).
Plain-English summary
Clinical Specialties Compounding Pharmacy is recalling specific lots of Cyclosporine 1% ophthalmic drops. The recall was initiated following FDA inspection findings that raised concerns regarding the company's quality control processes, specifically resulting in a lack of assurance of sterility.
The affected product is Cyclosporine 1% ophthalmic drops, 55 ml, manufactured by Clinical Specialties Compounding Pharmacy located in Augusta, Georgia. The recall covers five specific lots with expiration dates ranging from April 2013 to July 2013. These products were distributed in Florida, Georgia, and South Carolina.
Consumers who have purchased these specific lots should stop using the product and contact their healthcare provider or the pharmacy for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Cyclosporine 1% ophthalmic drops, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Ophthalmic
- Hazard
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 (8)
- Lot number CABCBEBB:35
- Exp date: 5/13/2013
- Lot number CABACAB:76 Exp date: 7/1/2013
- Lot number CABDAIAB:78
- Exp date: 4/8/2013
- Lot number CABDAEAC:80
- Exp date: 5/5/2013 and Lot number CABDCCAC:31
- Exp date: 5/23/2013.
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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