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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Eugia US LLC is recalling one lot of Methocarbamol Injection in US for white particles observed to be floating in the vial. The recall follows a customer complaint. Particulates in injection has potential to cause stroke and even death if it reaches blood vessels. Methocarbamol injection USP 1000 mg/10 ml, is used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The recall is initiated on 28 March 2024.
This is the fifth recall by Eugia US LLC from December 2023 as per USFDA Enforcement reports published. Other recalls are:
| S.No | Product | Reason for Recall | Recall Initiation |
| Â 1 | Nicardipine Hydrochloride Injection (2.5mg/ml) | Failed Impurities | 20 February 2024 |
| Â 2 | Nicardipine Hydrochloride Injection (2.5mg/ml) | Failed Impurities | 20 February 2024 |
| Â 3 | Methylprednisolone acetate Injectable Suspension, USP | Failed Dissolution Specification | 20 February 2024 |
| Â 4 | Tobramycin for Injection | Failed Stability specifications | 22 February 2024 |
An USFDA Inspection at Eugia US Manufacturing LLC in December 2023 had reported major discrepancies including deficient OOS investigations, CAPAs open beyond due dates, inadequate building controls, pressure cascading, cleaning and disinfection practices in aseptic areas.
Enforcement Report Methocarbamol
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