Testosterone Injection Recalled

Sun Pharmaceutical Industries Inc is recalling 3 lots of testosterone cypionate injection due to concerns about product impurities and sterility, according to the June 29, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects testosterone cypionate injection, 200 mg/mL, 1-mL single-dose vials (NDC 62756-015-40), from lots HAC1974A (Exp. 6/23), HAC1978A (Exp. 6/23), and HAC3427A (Exp. 8/23).

The products were manufactured by Sun Pharmaceutical Industries Ltd, Halol, India, and distributed within the United States and Puerto Rico by Sun Pharmaceutical Industries Inc, Cranbury, NJ.

Voluntarily initiated in the first half of June 2022 by Sun Pharmaceutical Industries Inc, the recall was designated Class II by the FDA during the latter half of the month.

The Class II recall designation signals that use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Testosterone cypionate injection is a prescription drug indicated for replacement therapy in males for conditions associated with symptoms of deficiency or absence of endogenous testosterone.