Class III · Low risk Terminated
Amiodarone Hydrochloride Injection
Reason Crystallization: Presence of visible particulate matter.
FDA Drug Recalls
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Class III · Low risk Terminated
Amiodarone Hydrochloride Injection
Reason Crystallization: Presence of visible particulate matter.
Class III · Low risk Terminated
Amiodarone Hydrochloride Injection
Reason Crystallization: Presence of visible particulate matter.
Class I · High risk Terminated
Bow & Arrow
Reason Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Class I · High risk Terminated
UP2, Dietary Supplement
Reason Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Class II · Moderate risk Terminated
R2103
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
StellaLife VEGA Oral Gel Rinse
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Pareira
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Silicea 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Natrum Sulphuricum 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Natrum Phosphoricum 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Natrum Muriaticum 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Magnesia Phosphorica 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Kali Sulphuricum 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Kali Phosphoricum 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Kali Muriaticum 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Ferrum Phosphoricum 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Cell Salts Combination 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Calcarea Sulphurica 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Calcarea Phosphorica 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Calcarea Fluorica 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
GSMS: Ranitidine Capsules 300 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
GSMS: Ranitidine Capsules 150 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Valganciclovir Hydrochloride for Oral Solution
Reason Presence of foreign substance: Brown/black particles found during stability testing.
Class II · Moderate risk Terminated
Ranitidine Syrup
Reason CGMP Deviations: Presence of NDMA impurity detected in product.