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 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
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 Terminated
buPROPrion Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications; during stability testing
Class II · Moderate risk Terminated
Heparin Sodium
Reason Subpotent: Low anti-factor IIa Potency.
Class III · Low risk Terminated
Methylprednisolone Acetate Injectable Suspension
Reason Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
Class II · Moderate risk Terminated
Buprenorphine Sublingual Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Famotidine Tablets
Reason Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Class II · Moderate risk Terminated
LORazepam Injection
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
HyperLyte CR Injection
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
HyperLyte CR Injection
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
Lidocaine 2% HCl Inj
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
Potassium Acetate Injection
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.