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.

Recall Number: D-0305-2021

Firm: Sagent Pharmaceuticals Inc

Classification: Class II

Status: Terminated

Report Date: 20210324

Initiation Date: 20210311

Termination Date: 20221228

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

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.