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

MORRISTOWN, N.J.–(BUSINESS WIRE)–Alvogen, Inc. is voluntarily recalling two lots of Fentanyl
Transdermal System 12 mcg/h transdermal patches to the consumer level. A
small number of cartons labeled 12 mcg/h Fentanyl Transdermal System
patches contained 50 mcg/h patches. 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.

Application of a 50 mcg/h patch instead of a prescribed 12 mcg/h patch
could result in serious, life threatening, or fatal respiratory
depression. Groups at potential increased risk could include first time
recipients of such patches, children, and the elderly. To date, Alvogen
Inc. has not received any reports of adverse events related to this
issue.

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:

Lot 180060 of Fentanyl Transdermal System, 12 mcg/h, expiration date
05/2020.

Lot 180073 of Fentanyl Transdermal System, 12 mcg/h, expiration date
06/2020.

The mislabeled product is packaged in a 12 mcg/h primary carton. These
lots of Fentanyl Transdermal System were distributed Nationwide to the
pharmacy level.

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.

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.

Adverse reactions or quality problems experienced with the use of this
product may be reported to the FDA’s MedWatch Adverse Event Reporting
program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and
Drug Administration.