Sagent Pharmaceuticals Inc FDA Recalls

5 recalls on file across drugs, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25Class IIMay 19, 2023Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	May 19, 2023
Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IClass IIMay 19, 2023Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	May 19, 2023
Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25Class IIMay 19, 2023Lack of Assurance of Sterility	Lack of Assurance of Sterility	Class IIDrugs	May 19, 2023
Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or SubcutanClass IIFeb 28, 2023Labeling: Not elsewhere classified	Labeling: Not elsewhere classified	Class IIDrugs	Feb 28, 2023
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per caClass IIMar 11, 2021Lack of Assurance of Sterility: customer complaints of loose	Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-	Class IIDrugs	Mar 11, 2021