Sun Pharmaceutical Industries’ US-based subsidiary issued the voluntary nationwide recall on Friday November 24, stating the metformin hydrochloride oral solution 500mg/5mL was made by a contract manufacturer.
According to the Indian-headquartered firm, two lots of the drug were found to be contaminated with the fungus Scopulariopsis brevicaulis during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET).
“Use of Riomet potentially could result in a risk of infection, especially in the immunocompromised patient,” said the firm in a statement.
“The most plausible portal of entry of Scopulariopsis brevicaulis is the respiratory tract, where it may cause pneumonia, sinusitis and disseminated infections.”
On Friday, the firm had not received any reports of adverse events related to the recall.
Who made what when?
Sun Pharma did not disclose the name of its manufacturing partner in the statement.
According to the US Food and Drug Administration, in 2010 Ranbaxy Laboratories marketed Riomet and outsourced manufacturing to its subsidiary, Ohm Laboratories.
Sun Pharma acquired Ranbaxy in 2015, along with Ohm Laboratories.
Sun Pharma did not respond to a request for comment before the time of publishing.