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Medication Safety Alerts

Fentanyl Transdermal System 12 mcg/h transdermal patches- Voluntary Recall

April 21, 2019

On April 21, 2019, the United States Food and Drug Administration (FDA) issued a notice about a recall of Fentanyl Transdermal System 12 mcg/h transdermal patches. This recall was issued because some cartons labeled 12 mcg/h Fentanyl Transdermal System patches may have 50 mcg/h patches. 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 to plan members who may be using product affected by this recall.

You should not continue to use product that is affected by this recall. Please call your doctor right away for advice if you may be using affected product. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

This recall affects lot numbers 180060 exp. 05/2020 and 180073 exp. 06/2020. To see if you have affected product, please check the lot number. The lot number is on the bottom of the manufacturer’s box. If your product is not from lot number 180060 exp. 05/2020 or 180073 exp. 06/2020, it is not affected by this recall. If your product is from lot number 180060 exp. 05/2020 or 180073 exp. 06/2020, please contact the pharmacy that filled your prescription for more information including return instructions.

CVS Caremark Response:

This product is not carried by the CVS Caremark Mail Service Pharmacies. Please call a Customer Care representative toll-free at 1-866-823-5184 for more information.

If you are currently taking Fentanyl Transdermal System 12 mcg/h transdermal patches and have questions regarding this recall, please call your doctor or call Alvogen Inc. toll‑free at 1-866-770-3024 or visit www.alvogen.com. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov/.

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