410.649.2000 Local       

1.800.556.5522 Toll Free

Fentanyl Transdermal Patches Recalled Due to Product Mislabeling

Alvogen Inc. has issued a recall on two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level due to product mislabeling. Here, the pharmaceutical liability attorneys provide an overview of the recall.

Fentanyl Transdermal Patches Recalled After Product Mislabeling

As a result of the mislabeling of transdermal patches from the Fentanyl Transdermal System, two lots of transdermal patches have been voluntarily recalled by Alvogen Inc. Transdermal patches are for use by opioid-tolerant patients for pain management.

The FDA has announced that two lots of the transdermal patches are being recalled because a number of transdermal patch cartons labeled 12 mcg/h actually contained 50 mcg/h patches, which would be over four times the dosage on the label. Pharmacies have been informed of the issue and have been requested not to give out any products named in this recall. Alvogen Inc. has also stated they will be informing its customers and distributors by certified letter as well as organizing a system for the return and replacement of the recalled products.

Using a Mislabeled Transdermal Patch Could Result in Serious Consequences

While Alvogen Inc. has stated that they have not received any reports of negative events resulting from the mislabeled transdermal patches, application of a 50 mcg/h patch instead of a 12 mcg/h patch could result in severe or even fatal respiratory infection and other complications. In addition, first-time users of the transdermal patches, as well as young children and the elderly, are at an increased risk of experiencing a serious reaction to using the mislabeled product.

If you use Fentanyl Transdermal System 12 mcg/h patches and are unsure if your transdermal patches have been included in the recall, listed below are the two lots that have been recalled:

  • Lot 180060 of Fentanyl Transdermal System, 12 mcg/h, expiration date 05/2020
  • Lot 180073 of Fentanyl Transdermal System, 12 mcg/h, expiration date 06/2020

Consult a Pharmaceutical Liability Attorney Today If You Have Been Affected By the Recall

When a pharmaceutical product is defective, mislabeled or otherwise tampered with during or post-production, it has the capability of profoundly impacting a wide population of individuals in need of the product. That is why it is the responsibility of pharmaceutical manufacturers and distributors to ensure their products are properly packaged and in the correct dosages to avoid causing harm to patients.

The legal team at The Law Offices of Peter Angelos have experience representing victims of product mislabeling and can provide legal counsel to individuals who have had adverse reactions to using a 50 mcg/h transdermal patch instead of their normally prescribed 12 mcg/h patch. If you or a loved one is seeking representation as a victim of product mislabeling, contact The Law Offices of Peter Angelos today.