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Recall Notice Alvogen Fentanyl


URGENT!!!                     DRUG RECALL!!!                  URGENT!!!

   NDC     Description      Lot Number    Exp Date
47781042347    FENTANYL 12 MCG/HR PATCH 180060 5/1/2020
   180073 6/1/2020

Alvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h to the patient level. A small number of cartons labeled 12 mcg/h Fentanyl Transdermal System patches contained 50 mcg/h patches. The 50 mcg/h patches that were included in cartons labeled 12 mcg/h are individually labeled as 50 mcg/hr. This transdermal system is manufactured by 3M Drug Delivery Systems, St. Paul, MN.

Application of a 50 mcg/h patch instead of a prescribed 12 mcg/h patch could result in serious, life threatening, or fatal respiratory depression. Groups at potential increased risk could include first-time recipients of such patches, children, and the elderly. To date, Alvogen, Inc. has not received any reports of adverse events related to this issue.

The product is indicated for the management of pain in opioid tolerant patients and is packaged in primary cartons of five individually wrapped and labeled pouches. The affected Fentanyl Transdermal System lots include:

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.

The mislabeled product is packaged in a 12 mcg/h primary carton. These two lots of Fentanyl Transdermal System were distributed nationwide in the USA to wholesalers and pharmacies on or after 10/10/2018.

Alvogen, Inc. requests that you immediately take the following actions:

        1. Check to  see if  you have a 12 mcg/h product carton with either: 

                 o    Lot 180060,  expiration date 05/2020; or

                 o    Lot 180073,  expiration date 06/2020.

         2. If you no longer have a product carton, but filled a 12 mcg/h prescription, check to see if you have patch pouches individually labeled as 50 mcg/h with either:

                   o     Lot 180060, expiration date 05/2020; or
 
                   o     Lot 180073, expiration date 06/2020.

Patients that have product subject to this recall should immediately remove any patch currently in use and contact their health care provider.

Patients should contact Qualanex via telephone at 888-504-2012 (7:00am to 4:00pm M-F CST).

Qualanex will guide patients to the appropriate return location and will also provide patients with the recall product form that the patient is to complete.

If you have any product concerns or medical questions, please call Alvogen, Inc. at 866-770- 3024 or send an e-mail to pharmac ovigilance@alvogen.com.

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.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre- addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S Food and Drug Administration.

Contact:

ALVOGEN: ALVOGEN Service 888-504-2012