Fentanyl Chronic Pain Patch Recall

Fentanyl transdermal system CII patches sold in the United States by Actavis South Atlantic LLC and manufactured by Corium International Inc. were voluntarily recalled in February 2008. It was discovered that the fentanyl patches may have a fold-over defect, which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Although no reported injuries resulting from this issue occurred at the time of the recall, Actavis removed 14 lots of the dangerous drug from pharmacies and wholesalers as a precaution.

Fentanyl is a powerful Schedule II opioid medication given to patients for the management of constant, moderate to severe chronic pain that requires continuous opioid administration for an extended period of time. Direct exposure to the gel may lead to serious adverse affects such as possible overdose, which may be fatal, and respiratory depression.

Leaking or damaged fentanyl patches should not be used and anyone who comes in contact with fentanyl gel should carefully and thoroughly rinse exposed skin with a lot of water only; not using any soap.

Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches are labeled 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.

If you have fentanyl patches labeled with an Abrika or Actavis label, you should check them for the above lot numbers.

Defective patches that have leaked gel will not release effective pain relief. If you encounter affected patches that may be compromised in any way or damaged, immediately flush them down the toilet, being careful not to handle them directly.

Any adverse reactions from using Fentanyl patches should be reported to the FDA’s MedWatch Program as soon as possible by phone at 1-800-FDA-1088 or on the MedWatch website at www.fda.gov/medwatch.

A manufacturer that produces defective drugs or supplements can and should be held accountable for the personal injuries caused. Before a product or pharmaceutical is made available to patients and consumers, a manufacturing company is responsible for making a safe product. To prove that the manufacturer failed to uphold its obligation for producing a safe and reliable product, you need the knowledge, resources, and skills of an experienced PA drug injury attorney from Cherry Injury Law.

If you or a loved one has suffered any of the dangerous side effects mentioned here or any other serious health related side effects from exposure to Fentanyl opiod gel, you deserve to be compensated by the defective drug’s manufacturer or distributor. The experienced Philadelphia pharmaceutical drug litigation attorneys at Cherry Injury Law can help you during this difficult time and get you the compensation you are due. Call us today for a free pharmaceutical injury case evaluation.

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If you have been seriously injured in the state of Pennsylvania by the negligence of another and if you have questions or concerns about your legal rights, please don’t hesitate to call. Our Pennsylvania injury attorneys are available 24 hours a day to speak with you, and we welcome all calls at no charge. Contact us today at 610-816-0366.