May 22, 2023

Drug Recalls for Pain Medications

Two separate recalls have been issued for different pain medications across the country.

Teva Pharmaceuticals has voluntarily recalled specific lots of various strengths of fentanyl buccal tablets CII at the consumer level due to a labeling error. This recall has been initiated because safety updates were omitted in the Product Insert/Medication Guide (MG) that are provided with these recalled lots.

The main safety concern is a potential for incomplete information needed by health care providers and patients regarding safe use of the product. Not following, or not being aware of, the omitted safety updates in the Product Insert/Medication Guide (MG) could lead to life-threatening adverse events.

Thirteen lots of this medication are affected by the recall. While fentanyl is indicated for the management of breakthrough pain in cancer patients who are tolerant to around-the-clock opioid therapy, fentanyl products are seen in workers’ comp claims among patients with severe pain.

In other news, Family Dollar initiated a recall of various Advil (ibuprofen) over-the-counter products that were stored and shipped to certain stores on or around June 1, 2022 through March 31, 2023 by Family Dollar outside of labeled temperature requirements.

As ibuprofen is a common pain medication available over-the-counter, it is possible that workers’ comp patients may have purchased these impacted products for pain relief, without reporting it to their workers’ comp care team.

Exposure to high temperatures for too long can cause a medication to degrade and become ineffective or even harmful.

For ongoing coverage of the latest drug approvals and alerts impacting workers’ comp, visit Med Monitor online.

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