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Sagent Pharmaceuticals Inc

Complete recall history across all FDA and CPSC categories — 16 total recalls

Sagent Pharmaceuticals Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (16)

FDA drug safety enforcement actions by Sagent Pharmaceuticals Inc

Date Product Reason Class
May 19, 2023 Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharm... Lack of Assurance of Sterility Class II
May 19, 2023 Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharm... Lack of Assurance of Sterility Class II
May 19, 2023 Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd... Lack of Assurance of Sterility Class II
Feb 28, 2023 Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose ... Labeling: Not elsewhere classified Class II
Mar 11, 2021 Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial pac... Lack of Assurance of Sterility: customer complaints of loose crimped vial ove... Class II
Apr 30, 2019 Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL V... Lack of Sterility Assurance: Microbial growth detected during a routine simul... Class II
Mar 5, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Sin... Failed Impurities/Degradation Specifications: High out of specification resul... Class II
Mar 5, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Sin... Failed Impurities/Degradation Specifications: High out of specification resul... Class II
Mar 5, 2018 methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Sing... Failed Impurities/Degradation Specifications: High out of specification resul... Class II
Jun 13, 2016 Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - ... Presence of Particulate Matter; The firm received two product complaints for ... Class II
Mar 1, 2016 Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Sing... Cross contamination with other products: metronidazole Class II
Feb 23, 2015 Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5... Lack of Assurance of Sterility: Recall initiated due to FDA observations pert... Class II
Feb 23, 2015 Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only,... Lack of Assurance of Sterility: Recall initiated due to FDA observations pert... Class II
Oct 3, 2014 Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-... Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, ... Class II
Mar 4, 2014 Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag... Lack of Assurance of Sterility; leaking of premix bags Class II
Jun 7, 2013 VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconsti... CGMP Deviations: product was not manufactured under current good manufacturin... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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