Class II · Moderate risk Ongoing
Glutamine 25 mg/mL
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Glucosamine 200 mg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
GAC, L-Glutamine/L-Arginine/L-Carnitine 25 mg/100 mg/200 mg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dexpanthenol 250 mg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Calm Me
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Calcium Gluconate 10% Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
BiMix Phentolamine/Papaverine 2 mg/30 mg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
BiMix Phentolamine/Papaverine 1 mg/30 mg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
BiMix Phentolamine/Papaverine 0.06 mg/1.8 mg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
B-Complex
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Bcaa
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ascorbic Acid 500 mg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Amino Acid Recover Eaze
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Amino Energy Cocktail
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Desoximetasone Ointment USP
Reason Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Class II · Moderate risk Terminated
Lactulose Solution
Reason Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Class II · Moderate risk Terminated
L-Cysteine Hydrochloride Injection
Reason Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Class II · Moderate risk Terminated
L-Cysteine Hydrochloride Injection
Reason Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Class II · Moderate risk Terminated
Levoxyl
Reason Superpotent
Class II · Moderate risk Terminated
Papa/Phen/Prost
Reason Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Class II · Moderate risk Terminated
Papa/Phen/Prost
Reason Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Class II · Moderate risk Terminated
Metformin Hydrochloride Tablets
Reason Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Class II · Moderate risk Terminated
Fentanyl Citrate Injection
Reason Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Class II · Moderate risk Terminated
Phenazopyridine Hydrochloride Tablets
Reason CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk Terminated
Phenazopyridine Hydrochloride Tablets
Reason CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.