News
Notice: Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Patches Due to Product Mislabeling
Date: 05/07/19
Notice: Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Patches Due to Product Mislabeling
On April 19, 2019, the U.S. Food and Drug Administration (FDA) announced that Alvogen, Inc. was recalling two lots of Fentanyl Transdermal System 12 mcg/h patches to the consumer level due to discovering that a small number of cartons labeled 12 mcg/h Fentanyl Transdermal System patches actually had 50 mcg/h patches inside.
The FDA press release states the following:
Alvogen, Inc. is recalling two lots (180060 and 180073, expiration date of May 2020 and June 2020) of Fentanyl Transdermal System 12 mcg/h patches to the consumer level. This recall was prompted due to discovering that a small number of cartons labeled 12 mcg/h Fentanyl Transdermal System patches actually had 50 mcg/h patches inside. The 50 mcg/h patches, that were included in cartons labeled 12 mcg/h, are individually labeled as 50 mcg/h. This transdermal system is manufactured by 3M Drug Delivery Systems, St. Paul, MN. To date, Alvogen has not received any reports of adverse events related to this recall. Fentanyl Transdermal System patches are indicated for the management of pain in opioid tolerant patients and are packaged in primary cartons of five individually wrapped and labeled pouches. The identifying NDC # associated with Alvogen’s recalled product is 47781-0423-47.
Alvogen Inc. is notifying its distributors and direct customers by certified letter and is arranging for return and replacement of all recalled products. Pharmacies are requested not to dispense any product subject to this recall. Patients that have product subject to this recall should immediately remove any patch currently in use and contact their health care provider. Patients with unused product should return it to point of purchase for replacement.
Providers can review the FDA’s full press release by visiting the FDA website.
For questions or concerns, please reach out to Coordinated Care’s pharmacy benefits manager, Envolve Pharmacy Solutions’ Pharmacy Department by calling 1.800.782.2221.