Western Drug Recalls Cyclosporine Eye Drops Due to Sterility Concerns
Western Drug Inc. is recalling four containers of Cyclosporine 1% Opth Sol because the product lacks assurance of sterility. The recall covers distribution in eight US states.
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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a lack of sterility assurance for an ophthalmic product which poses a risk of serious infection, align with the 'Severe' criteria (Score 4).
Plain-English summary
Western Drug Inc. is recalling four containers of Cyclosporine 1% Opth Sol, a prescription eye drop. The recall was initiated because the product lacks assurance of sterility. The affected product is distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah.
The recall applies to all lots of the product. Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Cyclosporine 1% Opth Sol, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
- Manufacturer
- Western Drug
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 4
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 (1)
- all lots
Distribution
Part of a larger recall action
This product is one of 91 recalled by Western Drug 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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