Phenylephrine HCl Injection recalled over sterility concerns

Recall date

March 11, 2021

Source

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

Official notice title

Sagent Pharmaceuticals Inc recalls Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per c…

Recall number

D-0305-2021

FDA classification

Class II

Brand / firm

Sagent Pharmaceuticals Inc

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.

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

What was recalled

Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC: 25021-315-01.