Recalled fentanyl four times more powerful than labled

A pharmaceutical company is recalling some of the painkiller it manufactures that is more than four times as powerful as indicated on the carton’s label.

The Food and Drug Administration announced that Alvogen, Inc. is recalling two lots of Fentanyl Transdermal System transdermal patches because some cartons labeled 12 mcg/h actually contain 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 and were distributed to pharmacies nationwide.

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 says it has not received any reports of adverse events related to this issue.

The product is used to manage 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 is notifying its distributors and customers by certified letter and is arranging for return and replacement of all recalled products.

Pharmacies have been 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: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download 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.