FDA recalls Rugby brand lubricating eye drops nationwide for non-sterility
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops are being recalled nationwide due to non-sterility. The recall affects all lots of the 0.5 FL OZ bottles distributed.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This is an FDA Class I recall, which the rubric identifies as Critical severity. FDA Class I indicates a serious health hazard where non-compliance could cause or contribute to serious adverse health consequences. Non-sterile eye drops present a significant risk of ocular contamination and infection.
Plain-English summary
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, are being recalled nationwide. The product is distributed by Rugby Laboratories in Livonia, Michigan, under National Drug Code (NDC) 0536-1325-94. Approximately 1,492,344 bottles with all lot numbers have been distributed.
The recall is due to non-sterility. Non-sterile eye drops may be contaminated and could cause serious eye infections.
The recall affects all lots distributed nationwide within the United States. Consumers should not use this product.
The recalled product
- Product
- Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94
- Manufacturer
- Kilitch Healthcare India Limited
- Category
- Drug — Eye drops
- Affected units
- 1,492,344
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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