Class II · Moderate risk
5-Methy Tetrahydrofolate 5 mg/ml Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
5-Methyl Tetrahydrofolate
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Zonisamide capsules
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
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.