Medmonitor

An up-to-date timeline of U.S. Food and Drug Administration (FDA) approvals that could potentially impact workers' compensation. These include new drug and indication approvals, new dosages or formulations of existing products, and generics introduced to the market. Click through the interactive timeline below, or select the comprehensive list view.
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MedAlert Tag: Pain Management

Lot of Acetaminophen Injections Recalled, Contain Dexmedetomidine

July 22, 2024

One lot of acetaminophen injections 1000mg/100mL, (10mg/mL) was recalled (Lot No24070381), due to the possible presence of a bag labeled dexmedetomidine inside the acetaminophen overwrap. If a provider administers dexmedetomidine instead of acetaminophen, there are multiple potential adverse outcomes that may result including varying degrees of sedation, bradypnea, bradycardia, hypertension, and hypotension or more serious and potentially life-threatening outcomes. To date, the manufacturer has received one report of an adverse event.

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Lot of Methocarbamol Recalled Due to White Particles

March 27, 2024

Eugia US LLC – also known as AuroMedics Pharma LLC – initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) - 10mL Vial to the consumer level due to a customer product complaint for the presence of white particles floating inside of the vial. Methocarbamol is a muscle relaxant that may be used to relieve pain and discomfort caused by strains, sprains, and other muscle injuries. Administration of an injectable product that contains particulate matter may result in local irritation or swelling. If the particulate matter reaches the blood vessels or is injected intravascularly it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Eugia US LLC has not received any reports of adverse events related to this recall.

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FDA Warns Consumers Not to Buy or Use Artri and Ortiga Products

April 20, 2022

The FDA is warning consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to potentially dangerous hidden active drug ingredients not listed on the product label. These products are marketed as treatments for arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. These medications are sold on various websites and in some retail stores, making them easily accessible to injured workers who may purchase them to help manage pain. Certain Artri and Ortiga products contained undeclared dexamethasone, diclofenac sodium, and methocarbamol, all which come with safety risks when not used appropriately. Furthermore, these drugs can interact with an individual’s overall drug regimen, leading to additional safety concerns, including drug-drug or drug-disease interactions.

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Teligent Pharma Recalls Lidocaine Topical Solution Due to Super Potency

December 7, 2021

Teligent Pharma issued a recall for two lots of Lidocaine HCl topical solution USP 4% 50ml due to super potency. Lidocaine is used as a local anesthetic, but an increased lidocaine dose could lead to systemic toxicity depending on the duration of treatment and the specific patient. This can result in central nervous system reactions such as hypotension and cardiovascular collapse, along with severe morbidity and even death.

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