Western Drug Recalls Serum Tears 20% Opth Due to Sterility Concerns
Western Drug is recalling Serum Tears 20% Opth eye drops because the product may not be sterile. The recall covers three containers distributed nationwide.
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. The hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
Western Drug Inc. is recalling three containers of Serum Tears 20% Opth, a prescription eye drop, due to a lack of assurance of sterility. The product was manufactured by Western Drug Inc. in Springerville, Arizona.
The recall affects all lots of the product. Distribution was nationwide, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah.
Consumers should stop using the product and contact their healthcare provider or pharmacist for instructions on disposal or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Serum Tears 20% Opth, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
- Manufacturer
- Western Drug
- Category
- Drug — Ophthalmic
- Affected units
- 3
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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