Recall archive / 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. Source coverage and dates.
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
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.
| 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.
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.