---
title: "Rugby: OTC Ophthalmic Sterile Drops — FDA announcement Nov 1, 2023 | Is It on Recall"
description: "Insanitary manufacturing conditions"
url: https://isitonrecall.com/recall/fdapress-95da3d14b68ee57d-rugby-otc-ophthalmic-sterile-drops/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA company announcement

# Rugby: OTC Ophthalmic Sterile Drops — FDA announcement Nov 1, 2023

Reported terminated

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Nov 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: OTC Ophthalmic Sterile Drops
- **Reason**: Insanitary manufacturing conditions
- **Classification**: Not supplied
- **Recalling firm**: The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories
- **Quantity**: Not supplied
- **Agency-reported status**: Terminated in FDA listing
- **Source record identifier**: 95da3d14b68ee57d

[Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/harvard-drug-group-llc-issues-voluntary-nationwide-recall-certain-rugbyr-laboratories-brand-eye)

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Brand Name \| Product Name \| Package Description \| NDC; Rugby® \| Polyvinyl Alcohol, 1.4% Lubricating Eye Drops \| 0.5 oz bottle (15 mL) \| 0536-1325-94; Rugby® \| Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) \| 0.5 oz bottle (15 mL) \| 0536-1282-94 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

**FDA company announcement, table 1**

| Brand Name | Product Name | Package Description | NDC |
| --- | --- | --- | --- |
| Rugby® | Polyvinyl Alcohol, 1.4% Lubricating Eye Drops | 0.5 oz bottle (15 mL) | 0536-1325-94 |
| Rugby® | Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) | 0.5 oz bottle (15 mL) | 0536-1282-94 |

Announcement retrieved Oct 1, 2026. [Official announcement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/harvard-drug-group-llc-issues-voluntary-nationwide-recall-certain-rugbyr-laboratories-brand-eye).

## Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Fda listing date**: Nov 1, 2023
- **Company announcement date**: Oct 31, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1- 866-891-1981 (8:00am-5:00pm EST Monday through Friday) or by email address harvarddrug8430@sedgwick.com. Consumers who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately.

[Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/harvard-drug-group-llc-issues-voluntary-nationwide-recall-certain-rugbyr-laboratories-brand-eye)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories records](https://isitonrecall.com/brand/the-harvard-drug-group-llc-dba-major-pharmaceutical-and-rugby-laboratories/)