Hypotension Injections Recalled

Nephron Sterile Compounding Center is recalling more than 1 million bottles of norepinephrine bitartrate in 0.9% sodium chloride injection due to a lack of assurance of sterility, according to the March 8, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes the following products from the Nephron 503B Outsourcing Facility in West Columbia, South Carolina, which were distributed throughout the United States:

• norepinephrine bitartrate in 0.9% sodium chloride injection, 4 mg/250 mL (16 mcg/mL), 250-mL single-dose container bottles, packaged 15 bottles per carton (NDC 69374-319-25), from lots NB2017A (Exp. 3/4/23), NB2019A (Exp. 2/21/23), NB2024A (Exp. 3/27/23), NB2025A (Exp. 3/24/23), NB2027A (Exp. 4/07/23), NB2035A (Exp. 5/22/23), NB2038A (Exp. 6/2/23), NB2045A (Exp. 6/25/23), NB2053A (Exp. 7/29/23), NB2058B (Exp. 8/16/23), NB2064A (Exp. 9/7/23), NB2069A (Exp. 9/25/23), and NB2071A (Exp. 10/1/23);
• norepinephrine bitartrate in 0.9% sodium chloride injection, 8 mg/250 mL (32 mcg/mL), 250-mL single-dose container bottles, packaged 15 bottles per carton (NDC 69374-316-25), from lots NB2015A (Exp. 2/27/23), NB2016A (Exp. 2/19/23), NB2021A (Exp. 3/5/23), NB2023A (Exp. 3/12/23), NB2026A (Exp.03/29/23), NB2029A (Exp. 4/21/23), NB2031A (Exp. 4/21/23), NB2033A (Exp. 5/10/23), NB2034A (Exp. 5/19/23), NB2037A (Exp. 5/25/23), NB2039A (Exp. 6/5/23), NB2041A (Exp. 6/14/23), NB2044A (Exp. 6/18/23), NB2050A (Exp. 7/19/23), NB2054A (Exp. 8/4/23), NB2057A (Exp. 8/12/23), NB2059A (Exp. 8/20/23), NB2061A (Exp. 9/14/23), and NB2067A (Exp. 09/22/23); and
• norepinephrine bitartrate in 0.9% sodium chloride injection, 16 mg/250 mL (64 mcg/mL), 250-mL single-dose container bottles, packaged 15 bottles per carton (NDC 69374-315-25), from lots NB2018A (Exp. 2/24/23), NB2022A (Exp. 3/8/23), NB2028A (Exp. 4/4/23), NB2032A (Exp. 4/24/23), NB2036A (Exp. 5/24/23), NB2043A (Exp. 6/17/23), NB2046A (Exp. 6/26/23), NB2049A (Exp. 7/21/23), NB2052A (Exp. 7/27/23), NB2062A (Exp. 9/13/23), and NB2068A (Exp. 9/23/23).

Nephron Sterile Compounding Center voluntarily initiated the recall February 22, 2023. On February 27, 2023, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Norepinephrine bitartrate injection is used to raise blood pressure in patients with severe, acute hypotension.