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 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
Ascorbic Acid Preserved Injection Solution
Mislabeling: preservative free product labeled as preserved.
Class II · Moderate risk
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial
Sub-potent Drug
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
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge
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
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.