Sagent Pharmaceuticals Inc Recalls

All product recalls associated with Sagent Pharmaceuticals Inc.

Get alerts for this brand

Recall Summary

Total Recalls

16

Past Year

0

Class I (Serious)

0

Most Recent

May 2023

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–16 of 16 recalls

Nafcillin Injection 1g (Sagent) – Sterility Risk (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 19, 2023Nationwide• Sagent Pharmaceuticals Inc

Nafcillin Injection 2g (Sagent) – Sterility Risk (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 19, 2023Nationwide• Sagent Pharmaceuticals Inc

Nafcillin Pharmacy Bulk Package (Sagent) – Sterility Risk (2023)

Lack of Assurance of Sterility

Class IIModerate

FDA

May 19, 2023

Nationwide

• Sagent Pharmaceuticals Inc

Heparin Sodium Injection (Sagent) – Labeling Issue (2023)

Labeling: Not elsewhere classified

Class IIModerate

FDAFeb 28, 2023Nationwide• Sagent Pharmaceuticals Inc

Phenylephrine Injection (Sagent) – sterility risk (2021)

Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.

Class IIModerate

FDAMar 11, 2021Nationwide• Sagent Pharmaceuticals Inc

Ketorolac Injection (Sagent Pharmaceuticals) – Microbial Growth (2019)

Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.

Class IIModerate

FDAApr 30, 2019Nationwide• Sagent Pharmaceuticals Inc

Methylprednisolone Sodium Succinate (Sagent) – Impurity Failure (2018)

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

Class IIModerate

FDAMar 5, 2018Nationwide• Sagent Pharmaceuticals Inc

Methylprednisolone Sodium Succinate (Sagent) – Impurity Failure (2018)

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

Class IIModerate

FDAMar 5, 2018Nationwide• Sagent Pharmaceuticals Inc

methylPREDNISolone Sodium Succinate (Sagent) – High Impurity (2018)

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

Class IIModerate

FDAMar 5, 2018Nationwide• Sagent Pharmaceuticals Inc

Oxacillin Injection (Sagent) – Particulate Matter (2016)

Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.

Class IIModerate

FDAJun 13, 2016Nationwide• Sagent Pharmaceuticals Inc

Fluconazole Injection (Sagent) – Cross Contamination (2016)

Cross contamination with other products: metronidazole

Class IIModerate

FDAMar 1, 2016Nationwide• Sagent Pharmaceuticals Inc

Atracurium Besylate 100mg Injection (Sagent) – Sterility Risk (2015)

Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.

Class IIModerate

FDAFeb 23, 2015Nationwide• Sagent Pharmaceuticals Inc

Atracurium Besylate 50mg Injection (Sagent) – Sterility Risk (2015)

Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.

Class IIModerate

FDAFeb 23, 2015Nationwide• Sagent Pharmaceuticals Inc

Ketorolac Tromethamine Injection (Sagent) – incorrect labeling (2014)

Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.

Class IIModerate

FDAOct 3, 2014Nationwide• Sagent Pharmaceuticals Inc

Zoledronic Acid Injection (Sagent) – sterility concerns (2014)

Lack of Assurance of Sterility; leaking of premix bags

Class IIModerate

FDAMar 4, 2014Nationwide• Sagent Pharmaceuticals Inc

Vecuronium Bromide (Sagent) – Manufacturing Deviation (2013)

CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.

Class IIModerate

FDAJun 7, 2013Nationwide• Sagent Pharmaceuticals Inc

Stay Informed

Sagent Pharmaceuticals Inc Recalls

Recall Summary

Nafcillin Injection 1g (Sagent) – Sterility Risk (2023)

Nafcillin Injection 2g (Sagent) – Sterility Risk (2023)

Nafcillin Pharmacy Bulk Package (Sagent) – Sterility Risk (2023)

Heparin Sodium Injection (Sagent) – Labeling Issue (2023)

Phenylephrine Injection (Sagent) – sterility risk (2021)

Ketorolac Injection (Sagent Pharmaceuticals) – Microbial Growth (2019)

Methylprednisolone Sodium Succinate (Sagent) – Impurity Failure (2018)

Methylprednisolone Sodium Succinate (Sagent) – Impurity Failure (2018)

methylPREDNISolone Sodium Succinate (Sagent) – High Impurity (2018)

Oxacillin Injection (Sagent) – Particulate Matter (2016)

Fluconazole Injection (Sagent) – Cross Contamination (2016)

Atracurium Besylate 100mg Injection (Sagent) – Sterility Risk (2015)

Atracurium Besylate 50mg Injection (Sagent) – Sterility Risk (2015)

Ketorolac Tromethamine Injection (Sagent) – incorrect labeling (2014)

Zoledronic Acid Injection (Sagent) – sterility concerns (2014)

Vecuronium Bromide (Sagent) – Manufacturing Deviation (2013)