Pharmacy Innovations Cyclosporine Eye Drops Recalled for Sterility Defect
Pharmacy Innovations is recalling Cyclosporine ophthalmic solutions (0.1%, 0.2%, 1%, 2%, and corn-oil-based 1%) due to lack of sterility assurance. FDA inspection found insanitary facility conditions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a prescription ophthalmic product with sterility assurance defects due to insanitary manufacturing conditions. While no illnesses or injuries have been reported, ophthalmic products with compromised sterility pose a significant potential risk of eye infection.
Plain-English summary
Pharmacy Innovations is recalling multiple strengths of Cyclosporine ophthalmic solutions: 0.1%, 0.2%, 1%, 2%, and a corn-oil-based 1% formulation. These are prescription-only eye drops manufactured at the facility located in Erie, Pennsylvania.
The recall was initiated after an FDA inspection of the manufacturing facility revealed insanitary conditions that compromised the assurance of sterility. Cyclosporine eye drops must meet strict sterility standards because they are applied directly to the eye, where contamination could cause serious infection.
The affected products were distributed nationwide in the United States. The recall affects all units produced under the specified lot codes.
Consumers with these medications should discontinue use and contact their pharmacy or healthcare provider. Do not use the product without consulting a healthcare professional about alternative treatments.
The recalled product
- Product
- Cyclosporine (A) 0.1%; Cyclosporine (A) 0.2%; Cyclosporine (A) 1%; Cyclosporine (A) 2%; Cyclosporine (A) - Corn oil - 1% Oph solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
- Manufacturer
- Pharmacy Innovations
- Category
- Drug — Ophthalmic Solution
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by Pharmacy Innovations 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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