Hypotension Injection Recalled

Sun Pharmaceutical Industries Inc is recalling 16,450 vials of norepinephrine bitartrate injection after routine product monitoring revealed a norepinephrine sulfonic acid impurity above the specification limit, according to the April 19, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects norepinephrine bitartrate injection, 4 mg/4 mL (1 mg/mL), in 4-mL single-dose flip-top vials (NDC 47335-615-40), packaged 10 vials per carton (NDC 47335-615-44), from lots G1510001 (Exp 11/23), G151002 (Exp 12/23), and G151003 (Exp 2/24). The product was manufactured by Gland Pharma Limited, Hyderabad, India, and distributed throughout the United States by Sun Pharmaceutical Industries, Cranbury, New Jersey.

Sun Pharmaceutical Industries initiated the recall on March 29, 2023. On April 10, 2023, the FDA designated the recall Class III. Under the recall classification, use of the affected injection is not likely to cause harm.

Norepinephrine bitartrate injection is a prescription drug indicated to raise blood pressure in adults with severe, acute hypotension.