Close on the heels of Ranbaxy Pharmacuetical's recall of generic version of cholestrol-lowering drug Lipitor, news of another Indian pharma firm initiating a voluntary recall has come to light.
According to the US FDA's enforcement report, Aurobindo Pharma had voluntarily recalled a batch of its drug Zolpidem from the US market owing to adulterated presence of foreign tablets.
“This product is being recalled because 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tablets USP 10 mg.”
Originally, Zolpidem was developed and marketed by Sanofi under the brand name — Ambien. Several drug majors including Aurobindo, Teva Pharma, Caraco Pharma, Torrent Pharma, Dr Reddy's Labs and Ranbaxy, sell the generic version of the drug in the US.
It may be mentioned that the US watchdog had recently imposed an import alert for products manufactured at Aurobindo's facility citing packaging discrepancies. The ban was lifted in June this year. However, one of the company's plants — Unit 6 — continues to be under the US import alert due to serious violations of good manufacturing practices. Unit-6 manufactures cephalosporin-based medicine.
Last week, Ranbaxy Pharma announced a voluntary recall of Lipitor from the US market fearing small glass particles in some of its dosages.
“The current fiscal has been challenging on account of full impact of the US FDA alert on our Unit-6 Cephalosporin manufacturing facility and mark-to-market loss on foreign currency borrowings,” P V Ramprasad Reddy, Chairman, Aurobindo had said.