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Tuesday, October 26, 2010

Safety Alert: Voluntary Recall

Safety Alert: Voluntary Recall - October 26, 2010 

Actavis Announces a Voluntary Recall of Transdermal Fentanyl 25 mcg

Actavis, a generic drug manufacturer, issued a voluntary recall of 18 lots of their 25 mcg Fentanyl patch on October 21, 2010. One lot was found to be defective, causing the medication to release too quickly into the bloodstream. This lot, along with 17 others, has been recalled. According to Actavis, the Food and Drug Administration (FDA) and wholesale and retail pharmacies have been notified.
For a listing of the affected lots, visit the Actavis website:
Regretfully, the company has failed to require the public to return their affected lots. As of October 25, the company’s website states, “Consumers are not being asked to return any product as this issue does not pose a threat of a serious injury or death.” Rapid absorption could lead to unintentional side effects such as increased sedation, nausea, vomiting and slowed breathing. The American Pain Foundation strongly urges Actavis to reconsider its first advisory and extend the recall to consumers.
Individuals who have these lots in their possession should:
  • Contact Actavis and demand a consumer recall and proper replacement. According to the FDA press release, Actavis has operators available to help customers, health professionals and consumers with the following information:
    •  Medical Issue/Adverse Event/Product Questions
      1-877-422-7452 (24 hours/day, 7 days/week)
    • Return/Reimbursement Questions
      1-888-896-4562 (24 hours/day, 7 days/week)
  • Contact the FDA and report your experience. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Online: 
  • Contact the pharmacy where this medication was filled and report that you are in possession of an affected lot.
  • Notify the health care provider who writes your pain medicine prescriptions and ask for guidance. 
  • Notify you insurance provider should a new prescription be written, so that it will be covered. 

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