New Delhi: Lupin’s US arm is recalling 11,706 bottles of Lisinopril tablets, used for treating hypertension, from the American market, USFDA said.
The product being recalled by Lupin Pharmaceuticals Inc is in the strength of 10mg, the US health regulator said in an Enforcement Report.
As per the report, the reason of the recall is, “presence of foreign substance: Product complaint was received of metal contaminant observed in one tablet.”
The product was distributed to distributors, mail order pharmacy, and supermarkets throughout the US, it added.
The ongoing voluntary recall is a class II recall, the report said.
As per USFDA, a class II recall is initiated in 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.”