FDA Recalls Certain Lots, Strengths of Fentanyl Pain Patch
FDA Recalls Certain Lots, Strengths of Fentanyl Pain Patch
The U.S. Food and Drug Administration (FDA) recently recalled all fentanyl transdermal patches of 25 mcg/hr strength under the brand names Duragesic and Sandoz, as well as varying strength patches of specific lot numbers and expiration dates under the brand name Actavis (formerly known as Abrika).
The FDA decided to recall these patches because they contain defects that may allow the fentanyl-containing gel to come into direct contact with the skin, which may cause potentially fatal effects including excessive drowsiness and respiratory depression (slowed breathing).
Because there are many different version of the fentanyl patch available to patients in generic and brand form, patients should examine the packaging of their fentanyl patches to find the name, lot number and expiration date, and compare this to the chart below. If your patch is among the recalled lots, please follow the instructions on the chart, and contact the manufacturer at the phone number listed for more information and instructions.
In the unlikely event that you cannot continue using the patch, contact your physician to be prescribed an alternative medication. If your patch is not among those recalled, you may continue using the patch as prescribed.
Please do not handle any of the recalled patches directly and do not open the foil pouch. Fentanyl patches that are cut or damaged in any way should not be used. If you come in contact with the fentanyl gel, you should thoroughly rinse exposed skin with large amounts of water only; do not use soap.
Always speak with your physician if you have any questions concerning your medications. For more information about the FDA’s statement about this recall, visit www.fda.gov. Thank you for your attention to this important matter.
Fentanyl Transdermal Patches Affected by FDA Recall
Note: 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. Anyone who has fentanyl patches labeled with an Abrika or Actavis label should check them for these lot numbers.
Warning: Do not directly handle the affected patches.
Brand |
Lot Number |
Expiration Date |
Action |
Actavis or Abrika Fentanyl Transdermal System >Check all strengths
|
27261 |
05/09 |
Call the Actavis Help Line at |
27317 |
05/09 |
||
27318 |
06/09 |
||
27319 |
06/09 |
||
27391 |
06/09 |
||
27409 |
06/09 |
||
27475 |
07/09 |
||
27476 |
06/09 |
||
27488 |
06/09 |
||
27514 |
07/09 |
||
27536 |
07/09 |
||
27537 |
08/09 |
||
27538 |
08/09 |
||
27545 |
07/08 |
||
Duragesic Fentanyl Transdermal System >Check the expiration date on the 25 mcg/hr strength only. |
All lots of the 25 microgram/hour (mcg/hr) |
ON or BEFORE |
Call the Duragesic Help Line at |
Sandoz Fentanyl Transdermal System >Check the expiration date on the 25 mcg/hr strength only. |
All lots of the 25 microgram/hour (mcg/hr)
|
ON or BEFORE |
Call the Sandoz Help Line at |