Class II · Moderate risk
BiMix Phentolamine/Papaverine 1 mg/30 mg/mL
Lack of Assurance of 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.
14,543 recalls, newest first.
Class II · Moderate risk
BiMix Phentolamine/Papaverine 0.06 mg/1.8 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
B-Complex (30 Ml)
Lack of Assurance of Sterility
Class II · Moderate risk
BCAA (30 Ml)
Lack of Assurance of Sterility
Class II · Moderate risk
Ascorbic Acid 500 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Amino Acid Recover Eaze
Lack of Assurance of Sterility
Class II · Moderate risk
Amino Energy Cocktail
Lack of Assurance of Sterility
Class II · Moderate risk
Desoximetasone Ointment USP
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Class II · Moderate risk
Lactulose Solution
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Class II · Moderate risk
L-Cysteine Hydrochloride Injection
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
L-Cysteine Hydrochloride Injection
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
LEVOXYL (levothyroxine sodium tablets, USP)
Superpotent
Class II · Moderate risk
Papa/Phen/Prost
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Class II · Moderate risk
Papa/Phen/Prost
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Class II · Moderate risk
Metformin Hydrochloride Tablets
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Class II · Moderate risk
Fentanyl Citrate Injection
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk
Salsalate Tablets
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk
Salsalate Tablets
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Phenazopyridine Hydrochloride Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
Indiomin MB URINARY ANTISEPTIC
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
AZUPHEN MB URINARY ANTISEPTIC Capsules
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk
UROPHEN MB URINARY ANTISEPTIC Tablets
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures