Class II · Moderate risk Terminated
Kali Sulphuricum 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
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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 Ongoing
Aurobindo Ranitidine Capsules 150 mg
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class II · Moderate risk Ongoing
Ranitidine Syrup
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class II · Moderate risk Ongoing
Aurobindo Ranitidine Capsules 300 mg
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class II · Moderate risk Ongoing
Aurobindo Ranitidine Caspules 150 mg
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class II · Moderate risk Ongoing
DG Health Acid Reducer Ranitidine Tablets 150 mg
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
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.
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Homatropine Methlybromide Oral…
Reason Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Class III · Low risk Terminated
Cefdinir for Oral Suspension USP
Reason Presence of Foreign substance: identified as a dead ant.
Class III · Low risk Terminated
Cefdinir for Oral Suspension USP
Reason Presence of Foreign substance: identified as a dead ant.
Class III · Low risk Terminated
Cephalexin for Oral Suspension USP
Reason Presence of Foreign substance: identified as a dead ant.
Class II · Moderate risk Terminated
LETS GEL KIT Convenience Pack
Reason Microbial contamination of non-sterile product.
Class II · Moderate risk Terminated
Potassium Phosphate
Reason Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Class II · Moderate risk Terminated
Lannett Ranitidine Syrup
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class I · High risk Terminated
0.9% Sodium Chloride Injection
Reason Presence of Particulate Matter.