Eugia US LLC (formerly known as AuroMedics Pharma LLC) is voluntarily recalling 1 lot of Methocarbamol Injection, USP 1000mg/10mL (100mg/mL) (single dose vial) due to the presence of white particles.
Methocarbamol Injection is a central nervous system depressant with sedative and musculoskeletal relaxant properties. It is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.
The recalled lot, Methocarbamol Injection, USP 1000mg/10mL (100mg/mL); NDC code 55150-223-10; Lot# 3MC23011; Expiration Date November 2026, was distributed nationwide to wholesalers between January 12, 2024 to January 16, 2024. The recall was initiated after a customer discovered white particles floating inside of the vial.
At this time, there have been no reports of adverse events related to this recall. Administration of an injectable product that contains particulate matter can result in local irritation or swelling and potentially serious systemic events (eg, stroke, death).
Adverse reactions and quality issues should be reported to the FDA’s MedWatch program.
References:
US Food and Drug Administration. Eugia US LLC (f/k/a AuroMedics Pharma LLC) issues voluntary nationwide recall of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (single dose vial) due to presence of white particles. March 28, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eugia-us-llc-fka-auromedics-pharma-llc-issues-voluntary-nationwide-recall-methocarbamol-injection.