Class II · Moderate risk Terminated
Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable
Reason Lack of Processing Controls
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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 III · Low risk Terminated
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count
Reason Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
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.
Class II · Moderate risk Terminated
Tamsulosin Hydrochloride Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Lisinopril and Hydrochlorothiazide Tablets USP
Reason 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 Terminated
Timolol- Dorzolamide- Latanoprost P-F
Reason Subpotent Drug
Class II · Moderate risk Terminated
Timolol-Latanoprost P-F
Reason Subpotent Drug
Class III · Low risk Terminated
Nystatin and Triamcinolone Acetonide Cream USP100
Reason Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Class II · Moderate risk Terminated
Clobazam Oral Suspension
Reason Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk Terminated
Temozolomide Capsules
Reason CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.