Class II · Moderate risk
C-Papav/Phentol/Pge1 10mg/1mg/20mcg/Ml
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
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Class II · Moderate risk
C-Papav/Phentol/Pge1 10mg/1mg/10mcg/Ml
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Methylcobalamin 25mg/Ml Injection Pfs
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Mb12 Nac 13mg/48mg/Ml Inj Soln
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Mb12/Hb12 5mg/5mg/Ml Inj Soln
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Interferon Alfa2b 1milu/Ml Ophthal Solution
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Hydroxyprogesterone Capro 250mg/Ml Injection
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Hydroxocobalamin 25 Mg/Ml Injection Solution
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Hydroxocobalamin 5 Mg/Ml Injection Solution
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Gentamicin 30mg/Ml Inj Solution Sdv
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
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