Class II · Moderate risk Terminated
C-Dexamethasone 24mg/Ml Inj Solution
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
C-Cromolyn Sod 20 Mg/2 Ml Inhalation Solution
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk Terminated
C-Calcium Glucnate 1% Injection Soln
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk Terminated
C-Atropine Sulf Ophth 0.02%
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk Terminated
C-Atropine Sulf Ophth 0.01%
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk Terminated
C-Albumin 5% Ophth Solution
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk Terminated
C-Acetylcysteine Ophth 10% Soln
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk Terminated
Mometasone Furoate Cream USP
Reason GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
Class II · Moderate risk Terminated
Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50…
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Papaverine/Phentolamine 30 mg/1 mg/mL Injectable
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Tobramycin Irrigation 80 mg/1000 mL Solution
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Gentamicin
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Dexamethasone Sodium Phosphate PF 24 mg/mL Injection
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Alprostadil 100 mcg/mL Injectable
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Acetylcysteine 2% Otic Drop
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Lisinopril and Hydrochlorothiazide Tablets USP
Reason Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Class II · Moderate risk Terminated
Monsel's
Reason 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 Terminated
Atorvastatin Calcium Tablet USP 80 mg
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Keppra
Reason Failed Dissolution Specifications.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP
Reason Lack of Assurance of Sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10
Reason CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.