Class II · Moderate risk
C-Acetylcysteine Ophth 10% Soln
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
FDA Drug Recalls
1,563 recalls, newest first
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.
Class III · Low risk
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of Assurance of Sterility: Bags have potential to leak.
Class II · Moderate risk
Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Class II · Moderate risk
Tamsulosin Hydrochloride Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Lisinopril and Hydrochlorothiazide Tablets USP
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
Class II · Moderate risk
Timolol- Dorzolamide- Latanoprost P-F
Subpotent Drug
Class II · Moderate risk
Timolol-Latanoprost P-F
Subpotent Drug
Class III · Low risk
Nystatin and Triamcinolone Acetonide Cream USP100
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.