Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling

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The product is indicated for the management of pain in opioid tolerant patients and is packaged in primary cartons of five individually wrapped and labeled pouches. The affected Fentanyl Transdermal System lots include: The mislabeled product is packaged in a 12 mcg/h primary carton. Alvogen Inc. is notifying its distributors and direct customers by certified letter and is arranging for return and replacement of all recalled products. Questions regarding this recall should be directed to Alvogen Customer Complaints by calling 866-770-3024 or sending an e-mail to pharmacovigilance@alvogen.com from Monday to Friday from 9:00 am to 5:00 pm EST. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

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