09/26/2024 | Press release | Distributed by Public on 09/26/2024 16:38
Key takeaways:
In September 2024, over 3 million tubes of lubricant eye ointment were recalled. The affected products include Refresh P.M. and Refresh Lacri-Lube, which were distributed across the U.S., Canada, Australia, and the United Kingdom.
The recall is due to a tube seal issue, which could result in leakage and potential contamination. If your product has been affected by this recall, it's best to stop using it. Tell your healthcare team if you experience eye infection symptoms such as eye pain, redness, or changes in vision.
Not all recalls are announced with a press release. To stay up to date on FDA recalls, you can visit the FDA website, subscribe to receive safety alerts, and check the weekly FDA enforcement report.
Over the last year, a variety of lubricant eye drops and ointments have been recalled. These recalls were issued due to potential contamination risks that could lead to serious eye infections. Now, in September 2024, another eye ointment recall has been issued.
Many people rely on these products for relief from dryness and irritation. But are these eye ointments still safe to use? Here's what you should know about the latest lubricant eye ointment recall, plus steps you should take if your product is affected.
The most recent eye ointment recall is due to a tube sealing issue. In these cases, the bottom of the tube may not be sealed properly, resulting in the ointment leaking out.
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Eye ointments are meant to be sterile - free of germs. If the tube isn't sealed properly, the ointment can become contaminated, which can increase the risk of eye infections.
Two lubricant eye ointment products are affected by this recall: Refresh P.M. and Refresh Lacri-Lube. Across the two products, over 3 million tubes of eye ointment have been recalled, with expiration dates ranging from 2024 to 2027. The products were distributed across the U.S., Canada, Australia, and the United Kingdom.
Not all recalls are announced with a press release. Instead, these recalled products were included on an FDA Enforcement Report. Below, you can find lot numbers and expiration dates of the affected products. Check to see if your product is on the list.
Product: Refresh P.M. Lubricant Eye Ointment (3.5 g tube) | |
Lot number(s) | Expiration date |
|
December 2024 |
|
January 2025 |
|
February 2025 |
|
April 2025 |
|
October 2025 |
|
November 2025 |
|
December 2025 |
|
January 2026 |
|
February 2026 |
|
March 2026 |
|
April 2026 |
|
May 2026 |
|
June 2026 |
|
July 2026 |
|
April 2027 |
|
May 2027 |
Product: Refresh Lacri-Lube Lubricant Eye Ointment (3.5 g tube) | |
Lot number(s) | Expiration date |
|
September 2024 |
|
October 2024 |
|
November 2024 |
|
June 2025 |
|
November 2025 |
|
February 2026 |
|
March 2026 |
|
May 2026 |
|
June 2026 |
|
July 2026 |
|
March 2027 |
If you see that your specific product is listed above, the first step is to stop using it. This is because there's a potential risk of contamination, which can put you at risk for an eye infection. Keep in mind that the sealing issue may not be obvious. So it's best to stop using the product, even if it's not visibly leaking.
If you have been using these products, contact your healthcare team if you notice eye infection symptoms such as eye pain, redness, or changes in your vision.
If you have additional questions about the recall, you can contact the manufacturer at 1-800-678-1605. Depending on where you purchased the eye ointment, you may be able to request a refund. For example, the Wegmans website indicates that you can return affected products purchased at the store for a full refund.
But even if your specific lot number and expiration date aren't on this list, it's still a good idea to take note if there's any leakage from the bottom of the tube. This is a sign that it's not sealed properly. In this case, it's a good idea to stop using the product and report the issue to the FDA. You can also contact the manufacturer at the number listed above.
There are other lubricant eye ointments available that haven't been recalled. There may also be unaffected lots of these particular products on store shelves. Your pharmacist can help you select an option to help meet your needs.
There are several ways that you can stay up to date on FDA recalls, including any updates to this particular recall. For general recall information, here are a few resources:
Check the FDA Recalls, Market Withdrawals, and Safety Alerts page
Subscribe to the FDA recall mailing list
Check the FDA Enforcement Reports, which tend to be more comprehensive
Follow the FDA's recall account on X (formerly known as Twitter)
In September 2024, certain lots of Refresh P.M. and Refresh Lacri-Lube lubricant eye ointments were recalled. This was due to a tube sealing issue, which could cause leakage and potential contamination. If your product has been affected by this recall, it's best to stop using it. Contact your healthcare team if you notice eye infection symptoms, such as eye pain or redness.
Allergen. (n.d.). Patient assistance.
National Library of Medicine. (2016). Eye infections.
U.S. Food and Drug Administration. (n.d.). MedWatch online voluntary reporting form.
U.S. Food and Drug Administration. (2024). Enforcement Reports.
U.S. Food and Drug Administration. (2024). Recalls, market withdrawals, & safety alerts.
U.S. Food and Drug Administration. (2024). Refresh P.M. Enforcement Report.
U.S. Food and Drug Administration. (2024). Refresh Lacri-Lube Enforcement Report.
Wegmans. (2024). Product recall: Allergan Refresh petroleum based eye drops.
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