CLASS I ONGOING Drug recall · Reported 14 Feb 2024 · FDA Enforcement Report
Rugby Polyvinyl Alcohol 4% Lubricating Eye Drops recalled
Kilitch Healthcare India is recalling Rugby Polyvinyl Alcohol 4% Lubricating Eye Drops, distributed nationwide in the US. The recall was initiated on 13 Nov 2023 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0293-2024
- FDA event ID
- 93357
- Recalling firm
- Kilitch Healthcare India, Navi Mumbai
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 13 Nov 2023
- FDA classified
- 5 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 13 Nov 2023 | Recall initiated by company | |
| 5 Feb 2024 | Classified by FDA | +84 days |
| 14 Feb 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Rugby Polyvinyl Alcohol 4% Lubricating Eye Drops recalled?
Yes. Kilitch Healthcare India recalled Rugby Polyvinyl Alcohol 4% Lubricating Eye Drops on 13 Nov 2023. The recall is Class I and its status is Ongoing. Recall number D-0293-2024.
Why was it recalled?
Non-Sterility
Which lots are affected?
All lots
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Kilitch Healthcare India
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Lubricant Eye Drops (Propylene glycol 6%) recalled | Kilitch Healthcare India | Sterility | Nationwide |
| Drug | CLASS I | Leader Dry Eye Relief (Polyethylene glycol recalledDry Eye Relief | Kilitch Healthcare India | Sterility | Nationwide |
| Drug | CLASS I | Lubricant Gel Drops (Carboxymethylcellulose sodium 0%) recalled | Kilitch Healthcare India | Sterility | Nationwide |
| Drug | CLASS I | Lubricant Gel Drops (Polyethylene glycol recalled | Kilitch Healthcare India | Sterility | Nationwide |
| Drug | CLASS I | Leader Dry Eye Relief (Carboxymethylcellulose Sodium 1%) recalledDry Eye Relief | Kilitch Healthcare India | Sterility | Nationwide |