US recall clouds Sun Pharma’s Halol facility in India

By Flora Southey contact

- Last updated on GMT

(Image: Getty/gustavofrazao)
(Image: Getty/gustavofrazao)
The discovery of particulate matter in testosterone cypionate injection vials has prompted Sun Pharma to issue a voluntary recall in the US.

The nationwide recall concerns 5,215 units of testosterone cypionate injection, USP, 200 mg/ml, Rx only, 10ml vials, used to replace testosterone in men who have developed low hormone-related conditions, such as erectile dysfunction.

In a US Food and Drug Administration (FDA) enforcement report​, Sun Pharmaceutical Industries US announced the recall was due to the “presence of particulate matter: organic and inorganic compounds detected in vials of product”.

Sun Pharma distributed the injections from its manufacturing facility in Halol, Gujarat, India.

The recall is the latest in a list of manufacturing concerns reported at the site. In 2015, the FDA issued a warning letter​ citing good manufacturing practice (GMP) concerns following an inspection at the same facility.  

In December 2016, the firm received a Form 483​ from the US regulator, citing nine observations, and another in February this year​, with three observations cited at the plant. According to Sun Pharma, the FDA cleared the facility four months later, in June 2018​.

Related topics: Regulatory & Safety, Regulations

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