Latest Recalls: REFRESH P.M. and REFRESH Lacri-Lube
In September 2024, Abbvie, the parent company of Allergan, issued a voluntary recall for specific lots of its REFRESH P.M. and REFRESH Lacri-Lube lubricant eye ointments. The action was triggered by a potential issue with the tube seal, which could cause a breach and lead to contamination. The recall affected over 3 million tubes of the combined products distributed across the United States, Canada, and other regions. Although no adverse events were reported in connection with this specific recall, the potential for contamination poses a serious risk to eye health.
How to Identify Recalled REFRESH Eye Ointments
The September 2024 recall applies to a wide range of lot numbers and expiration dates for REFRESH P.M. and REFRESH Lacri-Lube, with expiration dates ranging from 2024 to 2027. It is essential for consumers to check their products to see if they are part of the affected batches. The lot number and expiration date can be found on the bottom flap of the carton and on the crimp seal of the product tube.
To check your product, locate the following information on the packaging:
- Product Name: REFRESH P.M. or REFRESH Lacri-Lube
- Lot Number: Check against the lists provided by the manufacturer or the FDA enforcement report.
- Expiration Date: Confirm that the expiration date falls within the affected range.
Comparison of Recent Eye Product Recalls
To put the REFRESH ointment recall into context, it is helpful to compare it with other significant eye product recalls that have occurred recently. The reasons for recalls can vary, but sterility issues and contamination are common themes.
| Feature | September 2024: REFRESH P.M. & Lacri-Lube | February 2023: Global Pharma Healthcare (EzriCare, Delsam) |
|---|---|---|
| Product Type | Lubricant Eye Ointment | Artificial Tears (Eye Drops) and Ointment |
| Manufacturer | Abbvie (Allergan) | Global Pharma Healthcare |
| Reason for Recall | Breaches in tube seals leading to potential contamination | Contamination with a rare, drug-resistant bacteria (Pseudomonas aeruginosa) |
| Recall Classification | Class II | Initial voluntary recall, followed by FDA warnings and import alerts |
| Adverse Events | No adverse events reported | Linked to multiple infections, hospitalizations, vision loss, and at least one death |
| Consumer Action | Stop use of affected lots. Report any symptoms to a doctor. | Immediately stop using the products. Seek medical care if experiencing eye infection symptoms. |
The Risks of Using Recalled Eye Products
Eye ointments and drops are considered sterile products because they are applied directly to the eye, a sensitive and delicate organ. Any contamination can lead to serious eye infections, which can result in significant health complications. While the September 2024 recall of REFRESH P.M. and REFRESH Lacri-Lube has not been linked to specific infections, the potential risk is why a recall was issued. In contrast, the Global Pharma Healthcare recall in 2023 was linked to a severe drug-resistant bacterial outbreak that caused permanent vision loss and fatalities.
Symptoms of an Eye Infection
If you have used a recalled eye product, or are concerned about potential contamination, be aware of these common symptoms of an eye infection:
- Eye pain or irritation
- Redness of the eye or eyelid
- Swelling of the eye or eyelid
- Blurry vision or changes in vision
- Discharge from the eye (green or yellow)
- Increased sensitivity to light
Manufacturer's and FDA Actions
The voluntary recall initiated by Abbvie (Allergan) was classified by the FDA as a Class II recall, typically involving products that might cause temporary or reversible health issues. The manufacturer issued notices to retailers and healthcare professionals, advising them to quarantine and return the affected lots. Although a press release was not issued to consumers, the FDA's enforcement report detailed the recall. This is different from more severe Class I recalls, such as the EzriCare recall, which pose a higher risk of serious health consequences or death. The FDA continues to oversee product safety and provides regular updates on recalls through its website.
Conclusion
The most recent recall for REFRESH products involves specific lots of REFRESH P.M. and REFRESH Lacri-Lube lubricant eye ointments, issued in September 2024 due to potential tube seal defects. While this recall was preventative, aiming to avoid potential contamination, it serves as an important reminder for consumers to be vigilant about all eye products. Always check the manufacturer's website and the FDA's database for the latest recall information. If you suspect your product is part of a recall or experience any symptoms of an eye infection, stop using the product immediately and consult with a healthcare professional. Your eye health is a top priority, and staying informed is the first step toward protecting it.
What to Do if You Have a Recalled Product
- Stop Using Immediately: Cease using any affected REFRESH P.M. or REFRESH Lacri-Lube lubricant eye ointment.
- Check Packaging: Compare the lot number and expiration date on your product against the recalled list to be certain.
- Contact Manufacturer: For information on returns or credit, contact the manufacturer's provided number.
- Seek Medical Advice: If you experience any symptoms of an eye infection, contact an eye doctor immediately.
- Report to FDA: Quality problems can be reported to the FDA through their MedWatch Adverse Event Reporting program.
- Consider Alternative Products: Consult your pharmacist for recommendations on alternative, non-recalled eye care products.
This article provides general information. Consumers should always follow their healthcare provider's specific instructions and consult the latest FDA announcements regarding product recalls.
