FDA Recalls Due to Fentanyl Overdose
 

Fentanyl has been the subject of numerous FDA recalls and warnings.

January 2011 - Actavis is recalling certain lots of the company's fentanyl transdermal patches because they may release the active ingredient faster than they should. An accelerated release of fentanyl, a strong opioid narcotic, could lead to adverse events such as excessive sedation and respiratory depression.

The recall covers 25 mcg/hour patches from certain lots. Wholesalers and retailers who have patches from the recalled lots should return them to the company. Actavis is also asking patients to return any recalled product they have.

2010 Recall - Consumers encouraged to return any product in their possession from the October 2010 recall. Fentanyl Transdermal System: Recall - Potential for Active Ingredient to Release Faster Than Specified

FDA notified healthcare professionals and patients that laboratory testing identified a patch that released its active ingredient faster than the approved specification. An accelerated release of Fentanyl can lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing).

Fentanyl Transdermal System is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids. The product is manufactured for Actavis by Corium International in the United States.

Wholesalers and retailers are being asked to return the product they have on hand or in stock. See the Press Release for recalled product lots. The Control/Lot number appears on the bottom of the product box and on the black and white side of each individual patch packaging, in the lower left corner.

Read more patient information for fentanyl transdermal patch users.

Read about overdose claims for fentanyl transdermal patches.