Sagent Pharmaceuticals recalls
FDA enforcement reports naming Sagent Pharmaceuticals as the recalling firm.
- Recall reports
- 23
- Class I (serious)
- 2
- Most recent report
- May 27, 2026
- May 27, 2026Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, MfdDrug · Sagent PharmaceuticalsFailed Impurities/Degradation SpecificationsClass III
- Jun 19, 2024Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx o…Drug · Sagent PharmaceuticalsPresence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.Class I
- Jun 19, 2024Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, R…Drug · Sagent PharmaceuticalsPresence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.Class I
- May 22, 2024MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL),…Drug · Sagent PharmaceuticalsPresence of Particulate Matter: Potential for black particulates in the drug product.Class II
- Aug 2, 2023Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous…Drug · Sagent PharmaceuticalsLack of Assurance of SterilityClass II
- Aug 2, 2023Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a…Drug · Sagent PharmaceuticalsLack of Assurance of SterilityClass II
- Aug 2, 2023Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, MfdDrug · Sagent PharmaceuticalsLack of Assurance of SterilityClass II
- May 31, 2023Nafcillin for Injection, USP, 1 gram per vial, Rx only, MfdDrug · Sagent Pharmaceuticals IncLack of Assurance of SterilityClass II
- May 31, 2023Nafcillin for Injection, USP, 2 gram per vial, Rx only, MfdDrug · Sagent Pharmaceuticals IncLack of Assurance of SterilityClass II
- May 31, 2023Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, MfdDrug · Sagent Pharmaceuticals IncLack of Assurance of SterilityClass II
- Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx…
- Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 2…
- Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx o…
- methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose V…
- methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose V…
- methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vi…
- Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use…
- Fluconazole Injection, USP (in 0
- Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single…
- Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Mul…
- Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b)…
- Zoledronic Acid Injection 5 mg per 100 mL (0
- VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 1…
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