Alvogen, Inc. is voluntarily recalling two lots of fentanyl patches over mislabeled dosage information.
"A small number of cartons labeled 12 mcg/h Fentanyl Transdermal System patches contained 50 mcg/h patches," according to the U.S. Food & Drug Administration website. "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."
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The recalled patches were manufactured by 3M Drug Delivery Systems in St. Paul, Minnesota and sold nationwide. The recalled 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
"To date, Alvogen Inc. has not received any reports of adverse events related to this issue."
Those with questions regarding the recall should contact 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 are urged to contact their physician or health care provider if they have experienced any problems that may be related to taking or using the recalled fentanyl patches.
