The company is recalling 10 mg/mL vials of phenylephrine hydrochloride due to potential lack of sterility assurance in several lots of the product.
Sagent Pharmaceuticals has announced the voluntary US-wide recall of three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL). Recall of the product (manufactured by Indoco Remedies and distributed by Sagent) was initiated by Sagent after hearing customer complaints about potentially loose crimped vial overseals; a non-integral crimped vial overseal may result in a non-sterile product.
According to the US Food and Drug Administration (FDA), intravenous administration of a product intended to be sterile that is not actually sterile could result in serious systemic infections, which could end up being life-threatening. To date, Sagent has not received reports of any adverse events associated with this issue.
The Coalition for Epidemic Preparedness Innovations (CEPI) has set out a $3.5bn plan to ‘dramatically reduce or even eliminate the future risk of pandemics’. Its ambitions are for an ‘all-in-one’ vaccine against SARS, MERS-CoV and SARS-CoV-2 coronaviruses; as well as reducing vaccine development into a 100 day timeframe.
Denmark has halted its vaccination campaign with COVID-19 Vaccine AstraZeneca, as a precautionary measure while a full probe is ongoing into reports of blood clots in people who received the vaccine, including one case in that country, where a person died.