19 May 2023

Astral statement

Astral SteriTech Pvt. Ltd. is working with its distribution partners in the US to conduct a voluntary recall of all products manufactured at its facility that are within expiry. These semi-synthetic penicillin and cephalosporin products are sterile antibiotic powders used in hospitals and healthcare facilities to prevent infections. These products are sold generically under the names of the distributors. The FDA classified the recall as Class II, which is defined as a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 

Outside of the US, Astral is coordinating with its distribution partners regarding the appropriate next steps. Distributors, hospitals and other medical facilities are advised to cease use and quarantine any products they have immediately. 

To date, Astral has not received reports of adverse events relating to the issue giving rise to the recall.