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Sagent Pharmaceuticals FDA Recalls
7 recalls on file across drugs, 2 of them Class I and 7 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Class IIIMay 4, 2026Failed Impurities/Degradation Specifications |
| Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent PharmaceuticClass IMay 28, 2024Presence of Particulate Matter: Presence of particulate matt |
| Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent PharmaceuClass IMay 28, 2024Presence of Particulate Matter: Presence of particulate matt |
| MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx onClass IIApr 25, 2024Presence of Particulate Matter: Potential for black particul |
| Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novapluClass IIJul 11, 2023Lack of Assurance of Sterility |
| Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDCClass IIJul 11, 2023Lack of Assurance of Sterility |
| Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IClass IIJul 11, 2023Lack of Assurance of Sterility |