Class II · Moderate risk
Lisinopril tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
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Class II · Moderate risk
Lisinopril tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Lisinopril tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Famotidine tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Clarithromycin tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Azithromycin tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Azithromycin tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Azithromycin tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Amlodipine besylate tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Amlodipine besylate tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Amlodipine besylate tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk
Enalapril maleate and hydrochlorothiazide tablets USP
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Class II · Moderate risk
Losartan potassium tablets USP
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Class II · Moderate risk
Losartan potassium tablets USP
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Class II · Moderate risk
Losartan potassium tablets USP
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Class II · Moderate risk
Gentamicin Sulfate
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Ganciclovir Sodium
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Fluorouracil 4250mg / D5W 285mL
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
HYDROmorphone HCl PF
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Ceftazidime 2 gm / NS 50mL
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Morphine Sulfate
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Cefepime HCl
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Potassium Chloride
Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk
Vancomycin 1000mg / NS 100mL
Lack of Assurance of Sterility: Sterility of product is not assured.