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Pain Medication Recalled Over Contamination That Could "Cause Stroke," FDA Warns

An alert from the agency says the defect could lead to potentially fatal consequences.

There are many different ways to tackle tough pain, from over-the-counter products for general aches to more powerful prescription drugs for serious discomfort. These medicines can help people feel better and hopefully get back to a relatively regular routine. But now, the U.S. Food & Drug Administration (FDA) is warning that one pain medication is being recalled due to a potentially serious contamination issue.

RELATED: Walmart and Target Shoppers, Take Caution: Popular Mugs Recalled Over "Severe" Burns.

In an alert published by the agency on March 28, New Jersey-based pharmaceutical company Eugia US LLC announced it had begun a voluntary recall of one lot of its Methocarbamol Injection, USP 1000 mg/10 mL packed in 10 mL single-dose vials. The affected product is marked with lot number 3MC2301, expiration date Nov. 2026, and the National Drug Code (NDC) 55150-223-10. The company says the drug was shipped to distributors nationwide from Jan. 12, 2024 through Jan. 16, 2024.

According to the notice, the injectable medication is often used along with rest and physical therapy to help comfort patients suffering from "acute, painful musculoskeletal conditions." The company says it was alerted by a customer that small white particles appeared to be floating within one of the affected vials.

In some cases, receiving an injection that contains small contaminants can cause irritation and swelling in the area of the shot. But it can also be far more serious if the particles make their way into the bloodstream, where they can travel to vital organs and cause blood vessel blockages in the heart, lungs, or brain. The notice warns that this could lead to stroke and potentially death.

The company says it is in the process of notifying all customers about the situation by sending out recall letters and arranging to have all affected items returned and replaced. They warn that hospitals, pharmacies, and other institutions that have any of the recalled vials on hand should stop using them immediately.

The notice says that any customers with questions about the recall can reach Eugia US LLC from 8:00 a.m. to 5:00 p.m. Eastern Standard Time (EST) Monday through Friday by calling 1-866-850-2876 and selecting "Option 2." Anyone who believes they may have suffered an adverse health reaction as a result of using the product is urged to call their doctor immediately.

Unfortunately, this isn't the only medicinal recall that's been issued recently. On March 27, the FDA announced that Amneal Pharmaceuticals had pulled four lots of its Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL antibiotics from the market.

The drugs are typically used to treat "enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile." A manufacturing error led to some packages getting overfilled and surpassing the maximum daily dosage of 2 grams, which could lead to potentially serious side effects.

Zachary Mack
Zach is a freelance writer specializing in beer, wine, food, spirits, and travel. He is based in Manhattan. Read more
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