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Fentanyl Recall - Lawyer and Lawsuit

Below is FDA information regarding a fentanyl recall.  Pritzker | Olsen, P.A. is monitoring this recall and others involving fentanyl patches.  The firm has a national product liability practice, and attorneys at the firm have been interviewed by The New York Times, The Wall Street Journal, Lawyers USA, and other publications. In recognition of their accomplishments, Fred Pritzker, Elliot Olsen and Eric Hageman have been named "Super Lawyers" by Law & Politics magazine. To contact the firm, please call toll-free at 1-888-377-8900 or submit the firm's free case consultation form.

Injury or death associated with fentanyl may give rise to a product liability claim (see fentanyl recall information below) and/or a medical malpractice claim (see fentanyl lawsuit information).

Fentanyl Recall Information

March 1, 2008 - Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, announced a fentanyl recall involving all lots of Fentanyl transdermal system CII patches (“fentanyl patches”) sold in the United States by Actavis' subsidiary Actavis South Atlantic LLC.

Fentanyl is a dangerous medication and exposure to even small amounts of the drug can cause serious injury and death.

The recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States by Actavis South Atlantic LLC.

Fentanyl Recall Due to Possible Fold-Over Defect

The Fentanyl transdermal system patches being recalled may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel.  Exposure to fentanyl gel, via a leaking fentanyl patch, may lead to serious adverse events, including respiratory depression and possible overdose, which may be cause death. 

Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches are labelled with an Abrika Pharmaceuticals label, but the outer carton bears the Actavis logo with the following product names:

  • Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.
  • Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-18.
  • Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-18.
  • Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-18.

The lots covered by this recall have expiration dates between May 2009 and December 2009. For a detailed schedule of affected lot numbers, please click here.


 


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