#United States #Drug Safety #Morristown #Alvogen #Fentanyl Recall

Alvogen's Voluntary Nationwide Recall of Fentanyl Transdermal System

Alvogen, Inc. has taken the precautionary step of recalling one lot of its Fentanyl Transdermal System patches, specifically the 25 mcg/h dosage, due to a significant concern with the delivery mechanism of the product. The issue arises from a risk that multiple patches could be stacked together in one packaging pouch, potentially leading to serious health consequences for users, particularly those new to opioids, children, and the elderly.

Background of the Recall

On January 31, 2025, Alvogen announced the voluntary recall affecting Lot 108319 of its Fentanyl Transdermal System. These patches are manufactured by Kindeva Drug Delivery L.P. based in Northridge, California, and are distributed under Alvogen's private label. The recalls follow reports concerning adverse reactions stemming from the improper application of the patches, which could inadvertently cause users to receive an excessive dosage of fentanyl. Given the opioid's potency, such a mix-up could lead to severe respiratory depression, which can be life-threatening or even fatal.

Health Implications and Consumer Action

The recall has been prompted by a report of one serious adverse event linked to this issue, underscoring the urgency for immediate consumer action. The affected patches are meant for chronic pain management in patients who are already opioid-tolerant and require a long-term analgesia approach. Patients utilizing this patch must act swiftly: those with the impacted product should remove any patches currently in use and contact their healthcare providers without delay. Unused patches can be returned to their point of purchase for replacement.

The product was sold in primary cartons containing five individually wrapped patches, all of which were distributed across pharmacies nationwide. Alvogen is working proactively to notify all distributors and direct customers regarding the recall, also encouraging pharmacies to refrain from dispensing any affected products.

Next Steps for Consumers

Patients and consumers are urged to be vigilant and take necessary steps if they suspect they have received this specific lot of patches. For further information and to report any adverse effects, they can reach out to Alvogen’s Customer Complaints at 866-770-3024. Additionally, any reactions or quality issues must be reported to the FDA’s MedWatch program, ensuring that safety measures and regulatory actions can be effectively taken.

The U.S. Food and Drug Administration (FDA) has been informed of this voluntary recall, marking another important step in maintaining drug safety and ensuring that consumers are protected against potential health risks associated with pharmaceutical products. Alvogen is committed to resolving this issue quickly and safely for its consumers, emphasizing the importance of ongoing vigilance in the use of opioid medications.

Conclusion

This recall serves as a stark reminder for patients, pharmacists, and healthcare providers alike to be aware of the products being used. With opioids presenting significant risks, the integrity of drug delivery systems is paramount. Alvogen stands firm in its responsibility to public safety as it navigates the complexities of pharmaceutical recalls. Consumers are encouraged to remain informed and proactive in ensuring their safety when managing their health.