Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
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Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin and Sulbactam for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ampicillin for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Ascorbic Acid Preserved Injection Solution
Reason Mislabeling: preservative free product labeled as preserved.
Class II · Moderate risk Ongoing
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial
Reason Sub-potent Drug
Class II · Moderate risk Terminated
Lorazepam Injection
Reason Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Class II · Moderate risk Ongoing
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge
Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk Terminated
buPROPrion Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications; during stability testing