Multiple Recalls of Refresh P.M.
Refresh P.M. lubricant eye ointment has been subject to at least two distinct nationwide recalls in recent years. The first was in August 2015, initiated by Allergan due to reports of particulate matter. The second, more recent recall took place in September 2024 by AbbVie (the parent company of Allergan) and was related to a breach in the product's tube seal. Both events highlight the importance of regularly checking product safety information, especially for medications used in sensitive areas like the eyes.
The September 2024 Refresh P.M. Recall
Reason for Recall: The recall was initiated because of a breach in the tube seal of some products. Eye ointments are intended to be sterile, and a compromised seal could lead to leakage and contamination, potentially resulting in eye infections.
Recall Classification: The U.S. Food and Drug Administration (FDA) classified this as a Class II recall. This means that exposure to the compromised product may cause temporary or medically reversible adverse health consequences.
Affected Products and Distribution: This recall affected both Refresh P.M. and Refresh Lacri-Lube lubricant eye ointments. The products were distributed across the U.S., Canada, Australia, and the United Kingdom.
Affected Lots and Expiration Dates for September 2024 Recall:
- Expiration: December 2024: T4534, T4535, T4591, T4592
- Expiration: January 2025: T4660, T4661, T4696, T4697, T4709, T4772, T4773
- Expiration: February 2025: 387392, 387393, 387394, T4844, T4845
- Expiration: October 2025: 391688, 391734
- Expiration: November 2025: 394816, 394821
- Expiration: December 2025: 392616, 392620
- Expiration: January 2026: 392987, 393560
- Expiration: February 2026: 394927, 394929
- Expiration: March 2026: 395713, 395992, 396815
- Expiration: April 2026: 396816, 397248, 397315
- Expiration: May 2026: 397316, 397774, 397775, 397776, 398436, 398437
- Expiration: June 2026: 398621, 398643, 398739, 398944, 399001, 399255, 399270, 399271
- Expiration: July 2026: 399798, 399806, 400003
- Expiration: April 2027: 408668, 408723, 408737, 408853, 408895, 409261
- Expiration: May 2027: 409121, 409142
The August 2015 Refresh P.M. Recall
Reason for Recall: This recall was initiated voluntarily by Allergan after a small number of customers reported finding small black particles in the ointment. The particles were later identified as coming from the cap, which could shed fragments as it was unscrewed from the aluminum tube.
Adverse Events: Reports of adverse events included eye irritation, superficial eye injury, eye pain, and blurred vision, though no serious health complications were reported.
Affected Lots and Expiration Dates for August 2015 Recall:
- Expiration: May 2017: 85165, 85228
- Expiration: June 2017: 85244, 85351, 85374, 85397
- Expiration: July 2017: 85561, 85676, 85694
- Expiration: August 2017: 85834, 85977, 85985, 86073
- Expiration: September 2017: 85599, 86290, 86325, 86411, 86427, 86506, 86515, 86517
- Expiration: October 2017: 86746, 86792, 86789, 86809, 86822, 86822A
- Expiration: November 2017: 86932, 87100, 87068
- Expiration: December 2017: 87156, 87261
- Expiration: January 2018: 87493
- Expiration: February 2018: 87494, 87731
What to Do If You Have Recalled Refresh PM
- Stop Use Immediately: If your tube's lot number or expiration date matches a recalled product, stop using it, even if you don't notice any leakage or particles. The seal breach may not be visible to the naked eye.
- Check the Packaging: Locate the lot number and expiration date, which can typically be found on the bottom flap of the carton or on the crimp seal of the tube.
- Contact the Manufacturer: Reach out to the manufacturer, AbbVie (formerly Allergan), for questions about returns or reimbursement. The contact number for the 2024 recall was 1-800-678-1605.
- Consult a Healthcare Provider: If you have used a recalled product and experience any symptoms of an eye infection, such as eye pain, redness, or blurred vision, contact your healthcare provider immediately.
Comparison of Refresh PM Recalls
| Feature | August 2015 Recall | September 2024 Recall |
|---|---|---|
| Reason | Presence of black particulate matter originating from the cap | Lack of assurance of sterility due to a breach in the tube seal |
| Affected Product | Refresh P.M., along with other eye ointments | Refresh P.M. and Refresh Lacri-Lube |
| Risk Level | Consumer-level voluntary recall with adverse events reported | Class II recall, remote possibility of serious harm |
| Adverse Events | Eye irritation, superficial eye injury, eye pain, blurred vision | Contamination risk; no adverse events reported by FDA for this recall |
| Expiration Range | April 2017 to March 2018 | Primarily 2024 through 2027 |
Conclusion
Multiple recalls for Refresh P.M. have occurred due to different manufacturing issues, emphasizing the need for consumer vigilance. The September 2024 recall for sterility concerns, involving a large number of lots, and the August 2015 recall for particulate matter, both required users to stop use immediately. Consumers should always check the lot numbers and expiration dates on their packaging against official recall lists, and contact their doctor if they experience any concerning symptoms after using the product. Staying informed about medical product safety through reliable sources like the FDA and manufacturer announcements is the best way to ensure personal health and safety.
For more information on the September 2024 recall, consumers can reference the FDA Enforcement Report.
