Urgent Recall Alert – Methocarbamol Injection by Eugia US LLC

Attention Consumers, Healthcare Providers, and Distributors: 

Eugia US LLC, formerly known as AuroMedics Pharma LLC, announced a voluntary recall on March 28, 2024 of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) 10mL Single Dose Vial. The recall was initiated due to a customer complaint regarding the presence of white particles floating inside the product’s vial. 

Understanding the risks 

The presence of particulate matter in injectable products poses significant risks to consumers. Administration of such products may lead to local irritation or swelling. In severe cases, if the particulate matter enters the bloodstream, it can potentially travel to vital organs such as the heart, lungs, or brain, causing blockages in blood vessels and potentially resulting in serious complications like stroke or death. However, as of the date of the announcement, there were no reported adverse events related to this recall. 

About Methocarbamol Injection 

Methocarbamol injection USP 1000 mg/10 mL (100mg/mL) is commonly used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. 

Identifying the recalled product

The affected lot can be identified by its product name on the carton and vial label, along with lot number 3MC23011 and expiration date Nov 2026 (NDC 55150-223-10). 

Actions for consumers, healthcare providers, and distributors

Consumers: If you have questions or concerns regarding this recall or have experienced any adverse reactions, you are urged to contact Eugia US LLC at 1-866-850-2876 (Option 2) or via email at pvg@aurobindousa.com. Additionally, consult your physician or healthcare provider if you have used this product and encountered any issues. 

Healthcare Providers: Hospitals, pharmacies, and institutions are advised to discontinue the use and distribution of the recalled product immediately. Notify relevant healthcare professionals within your organization of this recall. 

Distributors: Wholesalers and distributors should cease distribution of the recalled product and arrange for its return/replacement. 

Report adverse events

Any adverse reactions or quality problems experienced with the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm, via regular mail, or by fax. 

Conclusion

This recall is being conducted in coordination with the U.S. Food and Drug Administration to ensure the safety of consumers. Immediate action is necessary to prevent potential health risks associated with the use of the recalled product. For further inquiries or assistance with product return, contact Qualanex at 1-800-505-9291 or email recall@qualanex.com. Stay informed, and prioritize your health and safety. 

Read the full recall announcement here.