Aurobindo's Eugia recalls one lot of muscle relaxant because of possible contamination

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来源: FiercePharma

Aurobindo subsidiary Eugia is voluntarily recalling one lot of methocarbamol injection following the possible discovery of white particles inside a vial.

Eugia, a unit of India’s Aurobindo, issued a voluntary recall of one lot of methocarbamol injection after a customer complained about finding white particles inside a vial.

The recall affects lot number 3MC23011 with an expiration date of November 2025, comprising 1,000 milligram/10-milliliter single-dose vials. The lot was distributed nationwide in January of this year, the company said in a letter posted to the FDA website and dated March 22.

The company said it hasn’t received any reports of patient problems related to the recall. Methacrarbamol is typically used to treat discomfort related to musculoskeletal conditions.

Eugia has recently come under FDA scrutiny following inspections at its facilities. In early March, the company was issued a Form 483 that outlined seven manufacturing problems at its injectables facility in Telangana, India.

That rebuke fell shortly after the U.S. regulatory agency slammed Eugia with a Form 483 aimed at its former New Jersey facility where inspectors in December noted “construction activities” in a warehouse near the firm’s microbiology lab, which could have posed a contamination risk.

In February, drug compounder Empower Pharmacy announced that it planned to buy the 170,000-square-foot Eugia facility for an undisclosed price and retain its workforce.

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