Sagent Pharmaceuticals Inc. is recalling four lots of its injectable seizure medication levetiracetam over concerns of container closure integrity on vials of the drug product. According to the recall announcement that was posted by the US Food and Drug Administration (FDA), Sagent says the issue affects reserve sample vials that could lead to a non-sterile product.
Administration of a product that is not sterile may cause serious systemic infections that could pose to be life-threatening. Levetiracetam injection is used for the treatment of certain types of seizures.
The levetiracetam injection (USP 500 mg per 5 mL) is packaged in a single-dose 5 mL vial. The nationwide recall of the vials affects lots distributed between March 2021 and November 2021.
Sagent said it has not received reports of any product complaints or adverse events linked to the closure integrity issue.
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Sagent Pharmaceuticals is alerting affected customers of the recall via email, fax and mail (either FedEx and/or certified mail). The company is providing arrangements for the return of any product on the recall list.
Sagent has also instructed people who use the injectable levetiracetam to immediately take a look at their supply of the medication, and if they are in possession of an affected lot, they should isolate it, halt any distribution of it and return as instructed.
Pharmacies that might have distributed the product are requested to identify their customers and reach out to them to notify them of the recall. Anyone who has the recalled product, including healthcare professionals, retailers and distributors, should stop using it and return it immediately.
Xtalks reached out to Sagent Pharmaceuticals for comment but did not receive a response.
Earlier this year, Sagent Pharmaceuticals faced similar issues with another one of its sterile injectables. In March, the company recalled three lots of phenylephrine hydrochloride, a drug commonly administered in hospitals to treat low blood pressure during anesthesia, after a customer complained of loosened crimped vial overseals. This was also associated with a risk of loss of sterility.
The integrity of container closures is critical to drug safety. Product container closure systems (CCS) are carefully designed and regulated to ensure the drug product is protected from environmental factors, such as temperature and light, to maintain its shelf life. In addition, there should also be compatibility between the product and its packaging to ensure that interactions between the CCS and product don’t compromise the integrity of the drug due to absorption, degradation or precipitation. Importantly, CCS materials must be safe for use and must function properly for the intended purpose.
Packaging issues have continued to plague pharma this year, including Merck who recalled about 22,000 vials of the antibiotic Cubicin (daptomycin) last month after a customer claimed they found a piece of glass in a vial after reconstituting the drug.
Teva Pharmaceuticals also had to pull a lot of its injectable cancer drug topotecan this summer following a complaint from a pharmacy over a glass particle being found in a vial of the medication.