Eye-stream Eye Wash Solution Recalled for Improper Storage
Mckesson Medical-Surgical has recalled Eye-stream eye wash solution nationwide due to storage conditions outside drug label specifications.
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 3/5 (High).
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 designation indicates a potential risk-of-harm scenario. Improper storage of a sterile eye care product could compromise its sterility and safety. The source documents no reported illnesses or injuries, fitting the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Eye-stream eye wash solution (4 FL OZ / 118 mL bottles, NDC 0065-0530-04) is being recalled nationwide. The recall affects 16 boxes of the product.
The recall was initiated because the product was stored outside the conditions specified on the drug label, constituting a Current Good Manufacturing Practice deviation. Improper storage of a sterile product could compromise its quality and safety.
This is a Class II recall. Consumers who have purchased this product should discontinue use and consult with their healthcare provider if they have questions or concerns about product exposure.
The recalled product
- Product
- Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Eye Care / Ophthalmic
- Affected units
- 16
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)
- Part# 0065053004
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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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