Actavis
On February 17, 2008 Actavis Inc. voluntarily recalled 14 lots of Fentanyl transdermal system Cll patches that were sold in the U.S. The patches were manufactured by Corium International Inc., a company that manufactures for Actavis. The Actavis Group produces and markets generic pharmaceutical products for National and International use. The company was formally known as Abrika Pharmaceuticals Inc., and the pouches around these patches recalled, are labeled with an Abrika Pharmaceuticals label, however the outer carton has the Actavis logo.
What is the patch?
The Actavis (fentanyl transdermal system)CII patch is a strong medication for moderate-to-severe chronic pain, that can provide long-lasting relief from persistent pain.
Fentanyl (the pain relieving medication in the Actavis patch) is an opiate derivative. Opiates are controlled substances because they are highly addictive, sometimes to the point of dependency. Through its patch technology it delivers fentanyl, an opioid pain medication, slowly into the body through the skin where it works to relieve pain.
The Actavis Fentanyl transdermal system patch is a strong medicine for serious pain. The Actavis patch should only be used when other less potent medicines have not been effective and when pain needs to be controlled around the clock.
What is the recall for?:
The Actavis recall is for certain Fentanyl patches sold within the U.S. by Actavis South Atlantic LLC, European patches are not affected. The patches may have a fold-over defect that could cause the patch to leak the fentanyl gel. If the patch leaks, not only is exposure a problem, the medication's controlled delivery could turn into the entire dose being released into the body at once. Exposure to the gel may lead to serious events including respiratory depression, as well as a possible overdose. Symptoms of a fentanyl overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness or coma, confusion, tiredness, cold and clammy skin, and small pupils. Continued exposure to uncontrolled amounts of fentanyl can lead to addiction and dependency.
The patches in affect are:
Lot # |
Strength |
Exp. Date |
27261 |
25 mch/hr |
5/09 |
27391 |
25 mch/hr |
6/09 |
27488 |
25 mch/hr |
6/09 |
27317 |
50 mch/hr |
5/09 |
27475 |
50 mch/hr |
6/09 |
27514 |
50 mch/hr |
7/09 |
27536 |
50 mch/hr |
7/09 |
27538 |
50 mch/hr |
8/09 |
27318 |
75 mch/hr |
5/09 |
27409 |
75 mch/hr |
6/09 |
27476 |
75 mch/hr |
6/09 |
27537 |
75 mch/hr |
8/09 |
27319 |
100 mch/hr |
5/09 |
27545 |
100 mch/hr |
7/09 |
The patches are under 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
On March 1st, 2008 Actavis Inc. has expanded its recall of its initial 14 lots. The remaining patches include:
Lot # |
Exp. Date |
Strength |
27540 |
Aug 09 |
25mcg/hr |
27584 |
Aug 09 |
25mcg/hr |
27666 |
Sep 09 |
25mcg/hr |
27759 |
Oct 09 |
25mcg/hr |
27611 |
Oct 09 |
25mcg/hr |
27762 |
Oct 09 |
25mcg/hr |
27761 |
Oct 09 |
25mcg/hr |
27832 |
Nov 09 |
25mcg/hr |
27747 |
Nov 09 |
25mcg/hr |
27758 |
Nov 09 |
25mcg/hr |
27903 |
Dec 09 |
25mcg/hr |
27573 |
Sep 09 |
50mcg/hr |
27576 |
Sep 09 |
50mcg/hr |
27667 |
Oct 09 |
50mcg/hr |
27668 |
Oct 09 |
50mcg/hr |
27581 |
Oct 09 |
50mcg/hr |
27763 |
Oct 09 |
50mcg/hr |
27751 |
Nov 09 |
50mcg/hr |
27586 |
Aug 09 |
75mcg/hr |
27572 |
Sep 09 |
75mcg/hr |
27582 |
Oct 09 |
75mcg/hr |
27583 |
Oct 09 |
75mcg/hr |
27745 |
Oct 09 |
75mcg/hr |
27746 |
Oct 09 |
75mcg/hr |
27539 |
Aug 09 |
100mcg/hr |
27574 |
Sep 09 |
100mcg/hr |
27575 |
Sep 09 |
100mcg/hr |
27577 |
Sep 09 |
100mcg/hr |
27578 |
Oct 09 |
100mcg/hr |
27579 |
Oct 09 |
100mcg/hr |
27580 |
Oct 09 |
100mcg/hr |
27610 |
Oct 09 |
100mcg/hr |
27612 |
Oct 09 |
100mcg/hr |
27743 |
Oct 09 |
100mcg/hr |
The patches could be labeled with Abrika and/or Actavis.
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