Hypotension Solution Recalled for Lack of Sterility Assurance

Sterility concerns have prompted SterRx to recall more than 350,000 single-dose bags of norepinephrine in sodium chloride, according to the July 26, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were distributed throughout the United States:

• norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% sodium chloride, 250-mL single-dose bags, packaged in 250 mL x 12 units per case (NDC 70324-552-01), from lots 490062 (Exp 7/22/23), 490151 (Exp 7/28/23), 490732 (Exp 8/6/23), 491591 (Exp 8/17/23), 491604 (Exp 8/18/23), 494418 (Exp 11/16/23), 494426 (Exp 11/17/23), 494434 (Exp 11/23/23), 496755 (Exp 11/25/23), 497424 (Exp 12/3/23), 497432 (Exp 12/4/23), 497441 and 497459 (Exp 12/7/23), 498005 (Exp 12/10/23), 499075 (Exp 1/22/24), 499083 and 499091 (Exp 1/25/24), 499391 (Exp 1/26/24), 501964 (Exp 3/23/24), 501972 (Exp 3/28/24), 501981 (Exp 3/30/24), 501999 (Exp 4/6/24), and 502001 (Exp 4/7/24);
• norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% sodium chloride, 250-mL single-dose bags, packaged in 250 mL x 12 units per case (NDC 70324-577-01), from lots 490071 (Exp 7/30/23), 490089 (Exp 8/4/23), 490118 and 490126 (Exp 8/5/23), 490169 (Exp 8/10/23), 491276 (Exp 8/11/23), 491284 (Exp 8/12/23), 491612 (Exp 8/18/23), 497467 (Exp 12/8/23), 497475 (Exp 12/9/23), 499104 (Exp 1/18/24), 499112 (Exp 1/19/24), 499121 and 499278 (Exp 1/20/24), 499358 (Exp 1/21/24), 502019 (Exp 3/24/24), 502027 (Exp 3/29/24), 502035 (Exp 4/5/24), 503513 (Exp 4/18/24), and 504217 (Exp 4/20/24); 
• norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% sodium chloride, 250-mL single-dose bags, packaged in 250 mL x 12 units per carton (NDC 70324-602-01), from lots 490097 (Exp 8/3/23), 490142 (Exp 8/10/23), 491292 (Exp 8/13/23), 494442 (Exp 11/26/23), 496763 (Exp 11/30/23), 496771 (Exp 12/1/23), 497408 (Exp 12/2/23), 497416 (Exp 12/3/23), 499438 (Exp 1/28/24), 501032 (Exp 2/8/24), 501059 (Exp 2/15/24), 502043 (Exp 3/28/24), 502051 (Exp 3/31/24), 503505 (Exp 4/4/24), 504031 (Exp 4/7/24), and 504250 (Exp 4/19/24); and
• norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% sodium chloride, 250-mL single-dose bags, packaged in 250 mL x 12 units per case (NDC 70324-702-01), from lot 490100 (Exp 7/27/23).  

SterRx voluntarily initiated the recall July 7, 2023. On July 19, 2023, the FDA designated it Class II. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Norepinephrine in sodium chloride Injection is used to raise blood pressure in adults with severe, acute hypotension.