FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Alvogen Recalls Mislabeled Fentanyl Patches

April 25, 2019
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Alvogen issued a nationwide recall of two mislabeled lots of its Fentanyl Transdermal System patches for relief of severe pain. The transdermal system is manufactured by 3M Drug Delivery Systems.

The product is packaged in primary cartons of five individually wrapped and labeled pouches. A small number of cartons that were labeled as containing 12 mcg/h patches actually contained 50 mcg/h patches. The 50 mcg/h patches that were included in cartons labeled 12 mcg/h were individually labeled as 50 mcg/h, the company said.

Use of the stronger patches could cause serious or fatal respiratory depression, especially for first time recipients. Alvogen said it did not receive any reports of adverse events.

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