Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby L
Summary
The FDA issued a Class I for Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ by Kilitch Healthcare India Limited. Reason: Non-Sterility.
Details
Source
Drug Recall
External ID
D-0293-2024
Action Date
2024-02-14
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: All lots
Quantity Affected: 1,492,344 bottles
Reason for Recall
Non-Sterility
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-13
Company
Navi Mumbai
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Kilitch Healthcare India Limited has 22 FDA actions in our database, including 22 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Kilitch Healthcare India Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Kilitch Healthcare India Limited have FDA actions?
Kilitch Healthcare India Limited has 22 FDA actions in our database, including 22 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0293-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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