
According to the FDA, Alvogen, Inc. is recalling one lot of their Fentanyl Transdermal System 25 mcg/h transdermal patches due to a potentially dangerous packaging issue. The company announced the recall on Friday, January 31st.
Alvogen’s Fentanyl Transdermal System 25 mcg/h transdermal patches are typically prescribed to patients with chronic and severe pain who no longer respond to other forms of pain management. Such patients are often described as being “opioid tolerant.” Each patch is dosed to deliver pain relief continuously for three days via an “opioid analgesic.” The product comes packaged in a yellow cardboard box marked “For Opioid-Tolerant Patients Only. Each box contains five 25 mcg/h patches. The lot number for the recalled product is 108319 with an expiration date of April, 2027. The recalled product was distributed to pharmacies throughout the United States. Patients can find the relevant lot number and expiration date printed on the top of the box.
To date, Alvogen Inc. has received one report of injury linked to use of the recalled fetanyl patches. The company says that the affected lot may contain patches that are “multi-stacked” in the same product pouch. Patients may not notice the extra patch or patches and may continue to apply the product, thereby introducing a much larger than intended dosage of fentanyl to their bodies. The increased dosage could result in “serious, life threatening, or fatal respiratory depression.” These risks are highest for kids, elderly patients, or patients who are using the transdermal fentanyl patches for the first time.
Alvogen Inc. issued a certified letter, advising all distributors and pharmacies of the recall. The company advises patients in possession of the recalled patches to cease use of the product immediately and return all unused patches to the pharmacy for a replacement. Patient should speak with their prescribing doctor if they’ve experienced concerning symptoms linked to use of the recalled product.
Anyone with questions or concerns about the recall can contact Alvogen Inc. by phone at 866-770-3024, Monday through Friday from 9 a.m. to 5 p.m. PST. Alternately, customers can email the company at alvogensmb@continuumindia.com.
Patients and health care providers can report any new adverse health events related to Alvogen’s Fentanyl Transdermal System 25 mcg/h patches through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an injury or adverse health outcome linked to safety issues with a drug, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medications to hospitals and health care providers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.