News & Press: Patient Safety

Safety Alert: Alvogen Inc. Voluntarily Recalling Fentanyl Transdermal System Due to Mislabeling

Tuesday, April 23, 2019  

SIS Patient Safety Alert 04/23/2019: Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling

This is an important alert from the Spine Intervention Society. SIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither SIS nor the FDA endorse either the product or the company.

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, Minnesota.

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.

See images example for lot 180073.

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.

  • Complete and submit the report online.
  • Regular Mail or Fax: Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

Source: Food and Drug Administration - Accessed 04/23/2019


Contact Us

120 E. Ogden Ave. Ste. 202
Hinsdale, Illinois 60521
P: 630.203.2252
Toll Free: 888.255.0005

© Copyright 2019 Spine Intervention Society 501(c)( 3) Privacy Policy  ::  Legal