The recall was announced by US company, Heritage Pharmaceuticals, on Saturday for the two products when two unreleased lots were found to be non-sterile and intended for the consumer market in the US.
The products, amikacin sulfate injection, 1g/4 mL, and prochlorperazine edisylate injection, 10mg/2mL, are manufactured by Emcure Pharmaceuticals, a company headquartered in India, while Heritage distributes the products across the US market.
In its announcement, Heritage stated that the recall was issued “due to microbial growth having been detected” in two separate lots of the medicines.
As a result, the company noted that this may indicate a ‘lack of sterility’ in other sublots of the products.
A patient who was administered a non-sterile injectable product could potentially contract a site-specific or system infection, leading to hospitalisation, organ damage or death, the company added.
At the time of the recall, Heritage had not received any reports of adverse events regarding patients who had received the products.
Amikacin sulfate injection is used for the treatment for serious infections due to gram-negative bacteria, and prochlorperazine edisylate injection is used to control severe nausea, as well as schizophrenia.
Both of the affected lots were delivered to distributors and wholesalers mid-way through last year, with the amikacin sulfate injection being released between June 2018 and August 2018, and the prochlorperazine edisylate injection between October 2018 and November 2018.
The recall is unfortunate for Emcure, which suffered a dent to its reputation when the US Food and Drug Administration (FDA) banned imports from Emcure’s Pune, India, facility after inspections discovered good manufacturing practice (GMP) deficiencies were revealed in 2016.