Lubricating Tears Eye Drops Recalled for Non-Sterility and Bacterial Contamination
Rugby Laboratories' Lubricating Tears Eye Drops are being recalled nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results at the manufacturing facility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall with confirmed bacterial contamination from environmental sampling at the manufacturing facility. Although no illnesses have been reported, Class I designation requires a minimum score of 4, reflecting the serious potential health consequences of non-sterile bacterial contamination in ophthalmic products.
Plain-English summary
Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles are being recalled nationwide. The product is distributed by Rugby Laboratories, Livonia, Michigan (NDC 0536-1282-94) and manufactured by The Harvard Drug Group LLC dba Major Pharmaceuticals. Approximately 65,880 bottles were affected across all lot numbers.
The FDA initiated this Class I recall due to non-sterility of the product. Environmental sampling at the manufacturing facility revealed positive bacterial test results and insanitary conditions that could compromise product sterility.
Consumers nationwide who have purchased this product are affected. Consumers should not use this product and are advised to consult a healthcare provider if they have experienced eye symptoms following use.
The recalled product
- Product
- Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94
- Category
- Drug — Ophthalmic
- Affected units
- 65,880
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 2 recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 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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