Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial recall — FDA D-0305-2021
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Overview of recall records associated with Sagent Pharmaceuticals Inc., including dates, categories and classifications where available.
Classification mix: Class II: 2.
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the…
This page summarizes recall records in which the official source identifies Sagent Pharmaceuticals Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.