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.
Reason for recall: Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Recall initiated: 20210311
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated