Alvogen Recalls Fentanyl Transdermal System
The company is recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches because of possible multi-stacking of patches.
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Alvogen announced on Jan. 31, 2025 that it is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches because of the potential of multi-stacked patches. It is possible the patches, which were manufactured by Kindeva Drug Delivery, are adhered one on top of the other in a single product pouch. The recalled lot, Lot 108319, 25 mcg/h, has an expiration date of 04/2027 and was distributed nationwide (1).
Fentanyl Transdermal System 25 mcg/h transdermal patches are used to manage severe and persistent pain in opioid-tolerant patients for an extended treatment period with a daily opioid analgesic, and for patients who don’t respond well enough to alternative treatment options. According to Alvogen, application of multi-stacked patches could cause serious or fatal respiratory depression, especially in first-time recipients, children, and the elderly.
While the company has not received any reports of adverse events related to the recalled product, as of the date of the press release, adverse events can be reported to FDA via its MedWatch Adverse Event Reporting program.
Final inspection of a product is essential in reducing recalls and ensuring the safety of drug products. In an episode of Pharmaceutical Technology®’s Ask the Expert series, Dirk Margosch, vice president Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, addresses steps that can be taken to mitigate risk in future batches of vials during secondary packaging after defective units have been found during an inspection (2). A thorough investigation should be performed to discover the root cause of the defects to prevent future occurrences.
“This [investigation] should involve reviewing all processes related to production. That means aseptic filling, visual inspection, assembly and secondary packaging, of course, always including the relevant packaging components. And then second, define the right preventive action, if the investigation comes, for example, to the conclusion that the defective vials were already present after the filling,” says Margosch.
Recalls are a factor in drug shortages, which can lead to patients not getting the medicines they need. Both FDA and the European Medicines Agency (EMA) have initiatives to monitor drug shortages that require manufacturers to provide information to regulators about things like product recalls and quality problems that might impact the availability of a drug. In January 2025, EMA announced the European Shortages Monitoring Platform is fully functional. This tool was created for marketing authorization holders and national competent authorities to directly report information about the supply, demand, and availability of authorized medicines to EMA during crises situations (3).
References
- FDA. Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System. Press Release. Jan. 31, 2024.
- Haigney, S. and Thomas, F. Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary Packaging. PharmTech.com, Jan. 23, 2024. https://www.pharmtech.com/view/ask-the-expert-product-inspection-part-one-risk-mitigation-in-secondary-packaging
- EMA. European Shortages Monitoring Platform Fully Operational for Monitoring of Shortages in the EU. Press Release. Jan. 29, 2025.
