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.