FDA MedWatch – Methocarbamol Injection USP, 1000 mg/10 mL (100 mg/mL) (Single Dose Vial) by Eugia US

TOPIC: Methocarbamol Injection USP, 1000 mg/10 mL (100 mg/mL) Single Dose Vial by Eugia US: Recall – Due to Presence of White Particles

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: Eugia US is recalling lot number 3MC23011 of Methocarbamol Injection USP, 1000 mg/10 mL (100 mg/mL) Single Dose Vial – 10 mL Vial due to a customer product complaint for the presence of white particles floating inside of the vial.

Risk Statement: 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.

For more information about this recall, click on the red button “Read Recall“ below.

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

RECOMMENDATIONS:

• Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

• Patients with medical questions regarding this recall or to report an adverse event can contact Eugia US at 1-866-850-2876 Option 2 or at pvg@aurobindousa.com.

• Hospitals/Institutions should inform health care professionals in your organization of this recall. 

• 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.

• If you have further distributed the recalled product lot, notify your accounts and/or any additional locations which may have received the recalled product.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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