Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
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Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lorazepam Injection
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
buPROPrion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications; during stability testing
Class II · Moderate risk
Heparin Sodium
Subpotent: Low anti-factor IIa Potency.
Class III · Low risk
Methylprednisolone Acetate Injectable Suspension
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
Buprenorphine Sublingual Tablets
CGMP Deviations