Stride Pharma Recalls Over 4.4 Lakh Cartons Of Testosterone Gel In US Market

madman

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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


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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Estradiol (E2)

A form of estrogen produced from testosterone. Important for bone health, mood, and libido. Too high can cause side effects; too low can affect well-being.

DHT

Dihydrotestosterone is a potent androgen derived from testosterone. Affects hair growth, prostate health, and masculinization effects.

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The biologically active form of testosterone not bound to proteins. Directly available for cellular uptake and biological effects.

Scientific Reference

Lakshman KM, Kaplan B, Travison TG, Basaria S, Knapp PE, Singh AB, LaValley MP, Mazer NA, Bhasin S. The effects of injected testosterone dose and age on the conversion of testosterone to estradiol and dihydrotestosterone in young and older men. J Clin Endocrinol Metab. 2010 Aug;95(8):3955-64.

DOI: 10.1210/jc.2010-0102 | PMID: 20534765 | PMCID: PMC2913038

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