Class II · Moderate risk
C-Gentamicin 30mg/Ml Inj Solution Sdv
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
FDA drug recalls in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 recalls, newest first.
Class II · Moderate risk
C-Edetate Disodium 1.5% Ophth Solution
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Dexamethasone 24mg/Ml Inj Solution
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Cromolyn Sod 20 Mg/2 Ml Inhalation Solution
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Calcium Glucnate 1% Injection Soln
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Atropine Sulf Ophth 0.02%
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Atropine Sulf Ophth 0.01%
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Albumin 5% Ophth Solution
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Acetylcysteine Ophth 10% Soln
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
Mometasone Furoate Cream USP
GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
Class II · Moderate risk
Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Papaverine/Phentolamine 30 mg/1 mg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Tobramycin Irrigation 80 mg/1000 mL Solution
Lack of Processing Controls
Class II · Moderate risk
Gentamicin
Lack of Processing Controls
Class II · Moderate risk
Dexamethasone Sodium Phosphate PF 24 mg/mL Injection
Lack of Processing Controls
Class II · Moderate risk
Alprostadil 100 mcg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Acetylcysteine 2% Otic Drop
Lack of Processing Controls
Class II · Moderate risk
Lisinopril and Hydrochlorothiazide Tablets USP
Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Class II · Moderate risk
MONSEL'S (Ferric Subsulfate)
Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.
Class II · Moderate risk
Atorvastatin Calcium Tablet USP 80 mg
Failed Dissolution Specifications
Class II · Moderate risk
Keppra (levetiracetam)
Failed Dissolution Specifications.