Pfizer’s Hospira issues recall after glass particles found in injectables

Hospira, a Pfizer company, has announced that they have issued a nationwide voluntary recall of three of their injectable products due to the potential of glass particles in the products.

The recalled products—, 4.2% sodium bicarbonate injection, 1% lidocaine HCI injection and 2% lidocaine HCI injection— have expiration dates of 1 August, 1 June, and 1 July, respectively, in 2024. They were distributed to wholesalers, hospitals, and institutions nationwide in the US and Puerto Rico 13-16 October this year.

Hospira announced that they have not received reports of any adverse events associated with this issue, but that potential serious adverse events, though highly unlikely, are probable.

Pfizer purchased Hospira back in 2015 in a $17bn acquisition.

This isn’t the first time that Pfizer’s sterile injectables business has faced quality issues.

Back in December last year, Hospira recalled one lot of its vancomycin hydrochloride injection vials packaged at the 1.5-gram dose due to glass particles in the vials. The lot, which comprised of 100 vials, was distributed nationwide in the US.

Earlier in 2022, Hospira issued a voluntary recall for one lot of propofol after a “visible particulate” was found in a vial during an annual inspection. The product was distributed nationwide in the US to wholesalers, hospitals, and the US Department of Defence in June 2020.

In the announcement by the US Food and Drug Administration (FDA), Pfizer said it places an emphasis on patient safety and product quality at every step in the manufacturing and supply chain process.