Cyclosporine 2% Ophthalmic Recalled Due to Sterility Concerns
Clinical Specialties Compounding Pharmacy is recalling Cyclosporine 2% ophthalmic due to FDA inspection findings regarding quality control and lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 87 ml of Cyclosporine 2% ophthalmic. The recall was initiated following FDA inspection findings that raised concerns regarding the quality control processes used to manufacture the product.
The specific hazard identified is a lack of assurance of sterility. The affected product was distributed in Florida, Georgia, and South Carolina. Four specific lot numbers are involved in this recall: CABCCIBC:89 (Exp 3/28/2013), CABDBEAB:07 (Exp 4/14/2013), CABDCIAB:42 (Exp 4/28/2013), and CABDCCAC:37 (Exp 5/23/2013).
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Cyclosporine 2% ophthalmic, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
- Manufacturer
- Clinical Specialties Compounding Pharmacy
- Category
- Drug — Ophthalmic
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 (7)
- 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.
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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