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 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
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 Ongoing
Safe tussin PM
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Ongoing
Pin-Away PYRENTAL PAMOATE
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Ongoing
Colic Calm
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Ongoing
Safe tussin DM
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Ongoing
VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility