Sagent Pharmaceuticals

FDA Regulatory Profile

Summary

Total Recalls
22 (2 Class I)
510(k) Clearances
0
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0553-2024Class IDocetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. forMay 28, 2024
D-0554-2024Class IDocetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. May 28, 2024
D-0499-2024Class IIMethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL MuApril 25, 2024
D-0935-2023Class IIOxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT PharmaceutJuly 11, 2023
D-0936-2023Class IIOxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-1July 11, 2023
D-0937-2023Class IIOxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx onlyJuly 11, 2023
D-0762-2023Class IINafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg,May 19, 2023
D-0764-2023Class IINafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT PharmaceutMay 19, 2023
D-0763-2023Class IINafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg,May 19, 2023
D-0435-2023Class IIHeparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For IntFebruary 28, 2023
D-0305-2021Class IIPhenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL SingMarch 11, 2021
D-1274-2019Class IIKetorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. forApril 30, 2019
D-0587-2018Class IImethylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only,March 5, 2018
D-0588-2018Class IImethylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only,March 5, 2018
D-0586-2018Class IImethylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, March 5, 2018
D-1450-2016Class IIOxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use, Sterile, NoJune 13, 2016
D-0780-2016Class IIFluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, March 1, 2016
D-0399-2015Class IIAtracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial,February 23, 2015
D-0398-2015Class IIAtracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, FFebruary 23, 2015
D-0027-2015Class IIKetorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NOctober 3, 2014