PReye Vitamin See Eye Drops Recalled for Lack of Sterility Assurance
PReye LLC is recalling PReye Vitamin See Antioxidant Preservative Free Eye Drops distributed in Colorado due to lack of assurance of sterility. All unexpired lots are affected.
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: This is an FDA Class II recall involving a sterile product (eye drops) with a manufacturing defect that could pose serious health risk. Lack of sterility assurance in ophthalmic products meets the Severe criteria as a Class II recall with potential for serious adverse health consequences, even without reported hospitalizations explicitly stated in the source.
Plain-English summary
PReye LLC is recalling PReye Vitamin See Antioxidant Preservative Free Eye Drops due to lack of assurance of sterility. The product is an eye drop formulation distributed by PReye, LLC, based in Golden, Colorado.
The recall affects approximately 50 to 60 bottles of the product. All lots within their expiration date are included in this recall. The product was distributed in Colorado.
Consumers who have purchased this product should stop using it. Anyone with questions or concerns should contact PReye LLC or consult their healthcare provider.
The recalled product
- Product
- PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
- Manufacturer
- PReye LLC
- Category
- Drug — Ophthalmic / Eye Drops
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 within expiry
Distribution
Distributed in 1 state:
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