Polyvinyl Alcohol Eye Drops Recalled for Non-Sterile Manufacturing Conditions
FDA recalls Polyvinyl Alcohol 1.4% Lubricating Eye Drops nationwide due to non-sterile manufacturing conditions found during inspection.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This product is classified as an FDA Class I recall, which is the FDA's most severe classification and meets the criteria for Critical severity. FDA Class I recalls are reserved for situations where there is a serious risk of adverse health consequences or death.
Plain-English summary
Polyvinyl Alcohol 1.4% Lubricating Eye Drops in 0.5 FL OZ (15mL) bottles are being recalled. The product (NDC 0536-1325-94) is distributed by Rugby Laboratories, Livonia, Michigan, and manufactured by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. All lots are affected, with approximately 1,271,810 bottles distributed nationwide.
The FDA recalled the product due to non-sterile manufacturing conditions. During inspection of the manufacturing facility, the FDA found insanitary conditions and positive bacterial test results from environmental sampling, indicating potential product contamination.
Consumers who have this product should not use it. Return the product to the pharmacy or retailer where it was purchased. Those who have already used this product and have questions or concerns should contact their healthcare provider.
The recalled product
- Product
- Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Category
- Drug — Ophthalmic / Eye Drops
- Hazard
- non-sterility
- bacterial-contamination
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.
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