Elevated risk U.S. Food and Drug Administration

Eugia US Methocarbamol Injection, USP 1000 mg/10 mL recall: Device & Drug Safety – Presence of Particulate Matter

Recall published 2+ years ago

Device & Drug Safety – Presence of Particulate Matter

Eugia US Prescription & OTC drugs — recalled prescription & otc drugs
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Sterility or particulate concern

The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

What the notice says: Risk Statement: Administration of an injectable product that contains particulate matter may result in local irritation or swelling.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
March 28, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Eugia US
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial)

What the company announced

FOR IMMEDIATE RELEASE – March 22, 2024– East Windsor, New Jersey, Eugia US LLC (f/k/a AuroMedics Pharma LLC) has 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.

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.

Methocarbamol injection USP 1000 mg/10 mL (100mg/mL), is used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. It is packaged in 10 mL and packed as 25 (vials) X 04 (Printed E-Flute cartons) X 01 (Shipper) 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) (See enclosed vial label).

The product label is as shown below:

Eugia US LLC (f/k/a AuroMedics Pharma 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. If you have further distributed the recalled product lot, notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall.

Consumers with medical questions regarding this recall or to report an adverse event can contact Eugia US LLC from 8:00 am to 5:00 pm (EST) Monday - Friday at:

1-866-850-2876 Option 2

[email protected]

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

If you have any general questions regarding the return of this product, please contact Qualanex at 1-800-505-9291 or email [email protected] (live calls received 7:00 am to 4:00 pm M-F CST).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 3MC23011
  • USP 1000 mg/10
  • Jan 16, 2024

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • Nov 2026

NDC number

On the carton and again on the bottle or blister label.

  • 55150-223-10

Package size

Match the net weight or the piece count on the front of the pack.

  • 1000 mg
  • 10 mL
  • 100 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Eugia US — The concern here is contamination of a product that bypasses the body’s normal defences, which is why the threshold for recalling it is low.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Report any infection or reaction you think the product caused to FDA MedWatch.
  3. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  4. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Remedy named in the notice: Eugia US LLC (f/k/a AuroMedics Pharma LLC) is notifying its distributors by recall letters and is arranging for the return/replacement of all recalled products.

Company contact: Eugia US LLC — Consumers: Eugia US LLC, 1-866-850-2876 Option 2, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Eugia US prescription & otc drugs recalled?

Device & Drug Safety – Presence of Particulate Matter Risk Statement: Administration of an injectable product that contains particulate matter may result in local irritation or swelling.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 3MC23011, USP 1000 mg/10, Jan 16, 2024; best-by date Nov 2026. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The notice says: Eugia US LLC (f/k/a AuroMedics Pharma LLC) is notifying its distributors by recall letters and is arranging for the return/replacement of all recalled products.

Where was the recalled product sold?

It was distributed nationwide.

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