Class II · Moderate risk
Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Ascorbic Acid 500 mg/ml Injectable Vial
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
L-Arginine 100 mg/ml Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Alprostadil 50 mcg/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Alprostadil 40 mcg/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Alprostadil 20 mcg/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Alprostadil 100 mcg/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Alprostadil 10 mcg/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Acetylcysteine 100 mg/ml Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Acetyl-L-Carnitine 500 mg/ml
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Acetyl-L-Carnitine 250 mg/ml Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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 · 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.