FDA Recall D-0440-2024

Eugia US LLC · East Windsor, NJ

Class I — life-threatening Ongoing 819 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10

Lot / code: Lot #: 3MC23011, Exp 11/30/2026

Quantity: 1,552 10ml x 25/carton

Reason for recall

Presence of Particulate Matter

Recall record

Recall number: D-0440-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-02-15
Classified by FDA Center: 2024-04-08
FDA published: 2024-04-17
Recalling firm: Eugia US LLC
Firm location: East Windsor, NJ

Drug identification

Brand name(s): METHOCARBAMOL
Generic name(s): METHOCARBAMOL
Manufacturer(s): Eugia US LLC
NDC(s): 55150-223
Route(s): INTRAMUSCULAR, INTRAVENOUS

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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