The patches are being recalled from the shelves of pharmacies and wholesalers as a safeguard measure to protect patients using Duragesic/Fentanyl. The manufacturer of the most recently recalled Duragesic/Fentanyl patches is Corium International, Inc. who is under contract with Actavis. The alleged concern is that the patches may pose a risk of overdose to those who use them for pain relief.
The newest recall follows on the heels of the less than one week old recall issued by PriCara and Sandoz for Duragesic patches manufactured by Alza, Corp. The patches for that first recall were 25 micrograms per hour and are primarily issued to people in lower weight brackets, children, and patients new to the medication.
People who take Duragesic have chronic pain conditions that require the assistance of an opioid that will release pain medication into their system continuously. The Duragesic patch is the means used since other ways are not as effective for pain relief in these patients. It gives a time released and continuous stream of pain suppressing power for people with severe pain issues due to medical conditions.
The FDA has allegedly released that Actavis used to be headed under the name of Abrika Pharmaceuticals, Inc. They have issued a solemn warning for consumers not to handle the patches directly with their bare hands. The Duragesic/Fentanyl patches may have the old company name of Abrika stamped on the pouch that contains the patch. However, the outside of the packaging may clearly list Actavis as the company.
Within the fourteen lots that are being recalled, four different dosage strengths are involved: 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, and 100 mcg/hr. Currently, all the lots being recalled expire between May 2009 up through August 2009. The following are the range of lot numbers being recalled: 27261 and 27317 (expiring 5/09), 27318-27319, 27391, and 27409 (expiring 6/09), 27475-27476, and 27488 (expiring 7/09), and 27537-27538, and 27545 (expiring 8/09).
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Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-08.
Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-08.
Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-08.
By Delsia Hartford