Recalls / Class I
Class ID-0440-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Brand name
- Methocarbamol
- Generic name
- Methocarbamol
- Active ingredient
- Methocarbamol
- Route
- Intramuscular, Intravenous
- NDC
- 55150-223
- FDA application
- ANDA206128
- Affected lot / code info
- Lot #: 3MC23011, Exp 11/30/2026
Why it was recalled
Presence of Particulate Matter
Recalling firm
- Firm
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 1,552 10ml x 25/carton
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-02-15
- FDA classified
- 2024-04-08
- Posted by FDA
- 2024-04-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0440-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.