Norepinephrine Bitartrate Injection recalled over sterility concerns

Recall date

July 29, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Teva Pharmaceuticals USA recalls Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-…

Recall number

D-0739-2021

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Product was distributed Nationwide, including Puerto Rico.

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01