FDA announces voluntary recall for Fentanyl patches

  • Published

On April 19, 2019, the Food and Drug Administration announced a voluntary recall of a small number of cartons labeled “Fentanyl 12 mcg/h Transdermal System patches.”  Fentanyl is used to manage pain for patients who can tolerate opioids. 

The recalled cartons contained 50 mcg/h patches instead of 12 mcg/h patches.

Using a 50 mcg/h patch instead of a prescribed 12 mcg/h patch could result in serious, life threatening, or fatal respiratory depression, said TRICARE officials. Groups at potential increased risk could include first time recipients of such patches, children and the elderly. To date, Alvogen, Inc. hasn’t received any reports of adverse events related to this issue.

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

Express Scripts, Inc. identified some TRICARE beneficiaries who potentially received recalled products through home delivery or retail network pharmacies on or after October 10, 2018. Letters notifying home delivery and retail beneficiaries who may have received currently affected products were mailed from Express Scripts, Inc. on behalf of the Department of Defense.

The DOD has notified all military hospitals and clinics of this recall and asked them to remove all affected products and confirm if any patients received the recalled products. Any patient impacted should be contacted.

Patients and prescribers should check the FDA website for potential changes in the recall status of this medicine.

People who use Fentanyl 12 mcg/h patches should check that the dosages on the packaging of individual patches are correct so they don’t take a wrong dosage, said officials.  Contact the local pharmacy at the number on the prescription label if it is the wrong dosage,  

More information about the recall and affected products is on the FDA website.

People can contact the pharmacy where they received their medication or the manufacturer, Alvogen, Inc., at 866-770-3024 or pharmacovigilance@alvogen.com.