Strides Pharma, Inc is recalling over 4.4 lakh cartons of Testosterone Gel in the US market due to the presence of a foreign substance, according to the US Food and Drug Administration. As per its latest Enforcement Report, the US health regulator said Strides Pharma, Inc is recalling 1,95,952 cartons of Testosterone Gel (1%), 2.5 grams and 2,44,412 cartons of Testosterone Gel (1%), 5 grams in the US market.
The Chestnut Ridge-based drugmaker, a part of Bengaluru-based Strides Pharma Science, is recalling the affected lot due to the 'Presence of Benzene', USFDA said.
The company initiated the Class II recall on March 5 this year.
As per the USFDA, a Class II recall is initiated in a situation in which the 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.
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