The FDA has issued an immediate recall of multiple lots of eyedrops, all manufactured in a facility they found unsanitary. Velocity Pharma, LLC in Dublin, Ohio, manufactures ophthalmic drops for Cardinal Health, Inc. and The Harvard Drug Group, LLC (Major Pharmaceutical/Rugby Laboratories). As of the writing of this notice, the FDA has received three adverse event reports from consumers who experienced vision blurriness, vision loss, and burning eyes. Upon inspection, the FDA’s environmental testing results were positive for the presence of bacteria.
SUMMARY
Date of Recall:
Announced: October 31, 2023
Public Notification: November 1, 2023
Name(s) of Drug:
Multiple eye drops named
See below
Company Name:
The Harvard Drug Group, LLC
Major Pharmaceutical
Rugby Laboratories
Cardinal Health, Inc.
LEADER
Drug Indication:
Dry Eyes
Eye Irritation
Product Description
The eye drops are packaged in 0.33oz and 0.5oz bottles, and packaged in a box labeled with brand information. Wholesale and retail pharmacy locations nationwide and online distributed the over-the-counter nasal sprays.
Reason for Recall
After receiving several adverse event reports from consumers, the FDA inspected the manufacturing facility and found it to be unsanitary. Bacterial testing was positive, indicating that the eye drops may contain harmful pathogens that can cause eye infections.
Impacts
Consumers who continue to use the contaminated eye drops are at risk of developing eye infections. These infections can lead to pain or loss of sight and may spread throughout the body, leading to death.
Lot Information
Consumers who use eye drops should check the listing below against the information on their eye drop packaging. If the information matches, read further to determine what actions must be taken to participate in the recall.
Brand Name |
Product Name |
Package Description |
NDC |
|
Rugby® |
Polyvinyl Alcohol, 1.4% Lubricating Eye Drops | 0.5oz Bottle (15mL) | 0536-1325-94 |
|
Rugby® |
Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) | 0.5oz Bottle (15mL) |
0536-1282-94 |
|
Leader™ |
Eye Irritation Relief (Polyvinyl Alcohol 0.5%, Povidone 0.6%, and Tetrahydrozoline Hydrochloride 0.05%) | 0.5oz Bottle (15mL) |
70000-0087-1 |
|
Leader™ |
Dry Eye Relief (Carboxymethylcellulose Sodium, 1%) | 0.5oz Bottle (15mL) |
70000-0089-1 |
| Leader™ | Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) | 0.5oz Bottle (15mL) |
70000-0090-1 |
|
Leader™ |
Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%) | 2 Bottles, 0.5oz Bottle (15mL) Each |
70000-0090-2 (Carton) 70000-0090-1 (Bottle)
|
| Leader™ | Dry Eye Relief (Polyethylene Glycol 400, 0.4% and Propylene Glycol, 0.3%) | 0.33oz Bottle (10mL) |
70000-0088-1 |
| Leader™ | Lubricant Eye Drops (Propylene Glycol, 0.6%) | 0.33oz Bottle (10mL) |
70000-0587-1 |
Have you found that your medication is part of the recall? Here’s what you should do:
Consumers
- Call your doctor right away. Report the use of the recalled medication.
- Monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
- Consumers with questions may contact Sedgwick, Inc. by phone at 1-855-215-4940. They are available Mon-Fri from 8:00 a.m. to 5:00 p.m. (EST). You can also contact them via email at Cardinalhealth7720@sedgwick.com or harvarddrug8430@sedgwick.com.
- If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock affected by the recall immediately.
- Contact Sedgwick, Inc. by phone at 1-855-215-4940 or utilize Cardinalhealth7720@sedgwick.com or harvarddrug8430@sedgwick.com to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock affected by the recall immediately.
- Contact Sedgwick, Inc. by phone at 1-855-215-4940 or utilize Cardinalhealth7720@sedgwick.com or harvarddrug8430@sedgwick.com to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
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