New Delhi: The US arm of drug firm Lupin is recalling 6,752 bottles of Testosterone Topical solution from the American market on account of the defective container, the USFDA said. The product is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
Lupin Pharmaceuticals Inc is recalling the 6,752 bottles of Testosterone Topical solution in the strength of 30mg/1.5mL manufactured by Lupin at its Pithampur plant, the US health regulator said in an Enforcement Report.
The reason for the recall is “Defective Container: Repetitive complaints received indicating pump not working,” it added.
The voluntary ongoing nationwide recall is a class III recall, the report said.
As per the United States Food and Drug Administration (USFDA), a class III recall is initiated in a situation,” in which use of or exposure to a violative product is not likely to cause adverse health consequences.”