Westlab Pharmacy Recalls Cyclosporine Eye Drops Due to Process Control Issues
Westlab Pharmacy is recalling Cyclosporine 1% Human Eye Drops due to a lack of process controls. The recall covers nationwide distribution.
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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when specific injury reports are not detailed but the classification implies potential for temporary or medically reversible adverse health consequences.
Plain-English summary
Westlab Pharmacy, Inc. is recalling Cyclosporine 1% Human Eye Drops (NDC 10002-2776-92) due to a lack of process controls. The affected product consists of 7 droptainers with Lot 07262018@7 and an expiration date of 08/25/2018.
The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The product was distributed nationwide.
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
- Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92
- Manufacturer
- Westlab Pharmacy, Inc. dba Westlab Pharmacy
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 7
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)
- Lot: 07262018@7 Exp. 08/25/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Westlab Pharmacy, Inc. dba Westlab 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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