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 ca
Recalled March 24, 2021 · FDA recall D-0305-2021 · Sagent Pharmaceuticals
Hazard
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product. · FDA Class II
Units
3716 cartons
Sold at
Nationwide in the USA and Puerto Rico
Description
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
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.
Manufacturer(s)
Sagent Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →