A familiar packaging snafu has led to another recall at Nichi-Iko Group’s Sagent Pharmaceuticals.
The Illinois-based manufacturer is recalling four lots of injectable levetiracetam, which is used to treat certain types of seizures, thanks to a “lack of container closure integrity” observed in reserve sample vials. The drug could become unsterile if the container it’s stored in doesn’t seal properly, Sagent explained in a recall announcement posted by the FDA Monday.
Injecting a non-sterile product could cause serious and potentially fatal systemic infections, the company warned. To date, Sagent said it hasn’t received any side effect reports linked to the suspect lots.
Sagent had similar problems with a different sterile injectable earlier this year. In March, the company pulled three lots of the hospital drug phenylephrine hydrochloride after a customer complaint flagged loose crimped vial overseals. In that instance, Sagent warned of a similar risk of loss of sterility.
The phenylephrine hydrochloride vials in that recall were manufactured by India’s Indoco Remedies and distributed by Sagent. The company didn’t say whether the injectable levetiracetam covered in this week’s recall had been made by another drugmaker.
The company shipped the batches in question between March and November this year. The lots were set to expire between June 2022 and June 2023. The drug comes in 5-ml single-dose vials, the company added.
Sagent didn’t immediately respond to Fierce Pharma’s request for comment.
Sagent isn’t the only drugmaker to grapple with packaging and sterility issues this year. Over the summer, Teva Pharmaceutical Industries pulled one lot of its cancer med topotecan injection after a pharmacy complaint flagged the presence of a single glass particulate in a vial of the drug.
Last month, Merck recalled nearly 22,000 vials of the antibiotic Cubicin after a customer said they found a piece of glass in a vial.
This story is brought to you by Fierce Pharma.