Sun Pharma recalls over 5.2k units of testosterone cypionate injections from US

The recall of 5,215 units is being done  on account of "presence of particulate matter: organic and inorganic compounds detected in vials of product."

Published: 05th August 2018 11:36 AM  |   Last Updated: 05th August 2018 11:36 AM   |  A+A-

Image used for representational purpose only. (File photo | Reuters)

By PTI

NEW DELHI: The US arm of the domestic drug major Sun Pharmaceutical Industries is recalling over 5.2 thousand units of testosterone cypionate injections from the American market, the latest enforcement report of the US health regulator has said.

Sun Pharmaceutical Industries Inc is recalling 5,215 units of 10 mL vials testosterone cypionate injections in the strength of 200 mg/mL, on account of "presence of particulate matter: organic and inorganic compounds detected in vials of product," the report said.

The injections were manufactured by Sun Pharmaceutical Industries at its Halol facility, it added.

As per the report by the United States Food and Drug Administration (USFDA), the ongoing voluntary nationwide recall is a class II recall.

According to the US health regulator, 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."

The injections are indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.

 

Stay up to date on all the latest Business news with The New Indian Express App. Download now

Comments

Disclaimer : We respect your thoughts and views! But we need to be judicious while moderating your comments. All the comments will be moderated by the newindianexpress.com editorial. Abstain from posting comments that are obscene, defamatory or inflammatory, and do not indulge in personal attacks. Try to avoid outside hyperlinks inside the comment. Help us delete comments that do not follow these guidelines.

The views expressed in comments published on newindianexpress.com are those of the comment writers alone. They do not represent the views or opinions of newindianexpress.com or its staff, nor do they represent the views or opinions of The New Indian Express Group, or any entity of, or affiliated with, The New Indian Express Group. newindianexpress.com reserves the right to take any or all comments down at any time.