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The US-based pharmaceutical company Lupine is recalling 6,752 bottles of topical testosterone solution from the US market due to the presence of a defective container, the USFDA said.
The product is indicated as a replacement therapy in men for conditions associated with a deficiency or lack of endogenous testosterone.
Lupine Pharmaceuticals Inc Recalls 6,752 Bottles of Testosterone Topical Solution at a Concentration of 30 mg / 1.5 ml Made by Lupine at Its Pithampur Plant, US Health Regulator Announced in Report on Application laws.
The reason for the recall is "Defective container: repetitive complaints received indicating that the pump is not working," adds the text.
The ongoing national voluntary recall is a class III recall, the report says.
According to the US Food and Drug Administration (USFDA), a Class III recall is initiated in a situation "in which use or exposure to an offending product is not likely lead to adverse health consequences ".
(With agency contributions.)
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