Fentanyl Transdermal System: Recall

Do you or someone you know use a Fentanyl patch for pain relief? If so, please take note of this recall.

October 21, 2010 - Morristown, NJ - Actavis Inc. today announced a voluntary recall to the wholesale and retail levels only of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches manufactured for Actavis by Corium International in the United States.

Actavis identified one lot of 25 mcg/hour Fentanyl patch (Control/Lot # 30349) shipped to market that contained one patch that released its active ingredient faster than the approved specification in laboratory testing. An accelerated release of Fentanyl from a 25 mcg/hour patch can lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing). The patches are packaged individually and boxed in quantities of five patches per box.

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.

As a precautionary measure, although unaware of any injuries associated with this issue, in addition to the aforementioned lot, Actavis is recalling the additional Control/Lot numbers noted below due to the possibility that additional patches may release active ingredient faster than the approved specification. 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.

Recalled Control/Lot #s
30041, Exp 12/2011	30258, Exp 03/2012
30049, Exp 12/2011	30349, Exp 03/2012
30066, Exp 12/2011	30350, Exp 03/2012
30096, Exp 01/2012	30391, Exp 03/2012
30097, Exp 02/2012	30392, Exp 04/2012
30123, Exp 01/2012	30429, Exp 04/2012
30241, Exp 02/2012	30430, Exp 04/2012
30256, Exp 02/2012	30431, Exp 04/2012
30257, Exp 03/2012	30517, Exp 04/2012

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)

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: www.fda.gov/medwatch/report.htm

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

Fax: 1-800-FDA-0178

Great non-health, non-nursing news

Those of you who know me or know my work, know that I am primarily a medical and health writer. I do dabble in other types of writing, but the health stuff is my bread and butter. And that's fine; it's what I know and what I'm good at.

Every so often, I like to reach beyond health and medicine, trying other types of writing. Some of this is writing essays. This isn't something I consciously decided to do until I took an essay-writing class. All of a sudden, I learned that, yes, I can do this.

I'm very pleased to announce that a book, a compilation of essays, has been published and one of the 28 essays is mine. To learn more, please visit Essays: Fits, Starts and More.

New CPR Guidelines

Hey folks - how many of you out in the Internet land know how to do CPR? Of course, you may say, but I don't leave the house - I'm on the computer all day long. ;-) But seriously, everyone should know how to do CPR. It's an amazing feeling knowing that you can possibly save a life just because you know what to do if someone's heart decides to stop.

When I taught first aid (many!) years ago, I used to say that I thought CPR should be taught in the high schools and be a requirement for graduation. But many people get the heeby-jeebies thinking about doing artificial respiration. I can't say I blame them.

Although I've done CPR more times than I can remember in the hospital situation, it was nothing compared to the one time I did it on the street. I have to say I didn't quite enjoy the AR part of the whole thing. Luckily, the breathing part is no longer an important part of the recommended CPR. In fact, it's been eliminated from the on-the-street recommendations.

In the "old" days, the thing to remember was ABC: Airway, Breathing, Circulation. Now, we just care about getting that circulation going. You just get to work pumping the heart. How fast? This is where being a BeeGees fan comes in. Believe it or not, the experts have found that the ideal compression rate for CPR is if the compressions are done to the beat of Staying Alive. How ironic is that?

Anyway, you can go to the American Heart Association to learn more about the new way to do CPR and who knows - maybe one day, you may save a life.