Drug recall: Velocity Pharma Lubricating Eye Drops non-sterility risk
Kilitch Healthcare is recalling all lots of Velocity Pharma Lubricating Eye Drop due to non-sterility issues. The product was distributed nationwide; consumers should stop using it immediately.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: FDA Class I classification for a sterility defect in eye drops carries a minimum severity score of 4 per the rubric. No deaths or serious injuries have been reported in the source material, therefore the score does not reach Critical (5).
Plain-English summary
Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), manufactured by Kilitch Healthcare India Limited, is being recalled due to non-sterility. The affected product was packaged in 3 bottles of 0.33 FL OZ (10 mL) each, with product code NDC 76168-502-30. Approximately 2,820 bottles have been distributed.
This recall affects all lots of the product and was initiated voluntarily by the manufacturer beginning November 13, 2023. The product was distributed nationwide within the United States. Non-sterile eye drops may contain harmful contamination that could cause eye infections or other serious complications.
Consumers who have purchased this product should stop using it immediately and should not apply it to their eyes. Consumers should consult with a healthcare provider if they have used the product and are experiencing any eye symptoms or concerns.
The recalled product
- Product
- Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL) each, Velocity Pharma, NDC 76168-502-30
- Manufacturer
- Kilitch Healthcare India Limited
- Category
- Drug — Eye Drops
- Affected units
- 2,820
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
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Kilitch Healthcare India Limited 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.
See all 22 products in this recall →Related recalls
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