Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Sagent Pharmaceuticals
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Presence of Particulate Matter: Potential for black particulates in the drug product.
Class I - Dangerous
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Labeling: Not elsewhere classified
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Class I - Dangerous
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.
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution.
Cross contamination with other products: metronidazole
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.
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 I - Dangerous
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.
Lack of Assurance of Sterility; leaking of premix bags
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.