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Drug maker Alvogen has issued a voluntary recall of two fentanyl patch products after it labeled them incorrectly.

The Food and Drug Administration said Friday that two lots of fentanyl patches are impacted by the recall. A small number of cartons labeled as containing 12 micrograms of the powerful drug actually contain 50 micrograms, and administering such a large dose could harm seniors and other patients.

“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,” the pharmaceutical company noted.

Alvogen said that it has not received any reports of adverse events related to the mislabeling. Affected batches 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.

Pharmacies are asked not to dispense any products, and patients to immediately remove, any patches impacted by the recall. Questions should be directed to Alvogen Customer Complaints by calling (866) 770-3024 or sending an e-mail to [email protected]. Product-related adverse events should be reported to the FDA’s MedWatch Program, the administration said.