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. This drug is commonly seen in workers’ comp, meaning this recall could potentially impact workers’ comp patients if they have received medication from the impacted lot.
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.
These injections were packaged in 10 mL and packed as 25 vials with NDC code as 55150-223-10. Eugia US LLC shipped the entire lot to wholesalers nationwide from Jan 12, 2024, through Jan 16, 2024. The product can be identified by product name on carton and vial label and with lot number 3MC23011 and Exp. Date: Nov 2026 (NDC 55150-223-10).
Eugia US LLC is notifying its distributors by recall letters and is arranging for the return/replacement of all recalled products. Wholesalers, hospitals, pharmacies, institutions, and doctors with an existing inventory of the recalled product lot should discontinue use, stop distribution and quarantine the product immediately.
For ongoing coverage of the latest drug approvals and alerts impacting workers’ comp, visit Med Monitor online.
