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Sagent Pharma Recalls Seizure Drug Levetiracetam Injection

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Sagent Pharmaceuticals, Inc. is recalling four lots of seizure drug Levetiracetam Injection, USP, to the user level across the United States, the U.S. Food and Drug Administration said.

According to the regulator, the lack of container closure integrity, found in reserve sample vials, may result in a non-sterile product.

The recall involves Levetiracetam Injection, USP 500 mg per 5 mL, which is used in the treatment of certain types of seizures. The product is packaged in a 5mL single-does vial, and was distributed across the country from March to November 2021.

Intravenous administration of a product intended to be sterile that is not sterile could result in serious systemic infections which may be life threatening.

However, the company has not received reports of any product complaints or adverse events associated with the issue to date.

The affected customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of, and return as directed the recalled lots of product.

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