Brand
Sagent Pharmaceuticals
7 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Sagent Pharmaceuticals and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-05-27FDA-DrugClass IIISagent Busulfan Injection recalled for impurity specifications failure
Failed Impurities/Degradation Specifications
- 2024-06-19FDA-DrugClass IDocetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
- 2024-06-19FDA-DrugClass IDocetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
- 2024-05-22FDA-DrugClass IIMethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10
Presence of Particulate Matter: Potential for black particulates in the drug product.
- 2023-08-02FDA-DrugClass IIOxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Lack of Assurance of Sterility
- 2023-08-02FDA-DrugClass IIOxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Lack of Assurance of Sterility
- 2023-08-02FDA-DrugClass IIOxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
Lack of Assurance of Sterility
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