Class II · Moderate risk
Silicea 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
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Class II · Moderate risk
Natrum Sulphuricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Natrum Phosphoricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Natrum Muriaticum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Magnesia Phosphorica 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Kali Sulphuricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Kali Phosphoricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Kali Muriaticum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Ferrum Phosphoricum 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Cell Salts Combination 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Calcarea Sulphurica 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Calcarea Phosphorica 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Calcarea Fluorica 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Aurobindo Ranitidine Capsules 150 mg
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class II · Moderate risk
Ranitidine Syrup
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class II · Moderate risk
Aurobindo Ranitidine Capsules 300 mg
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class II · Moderate risk
Aurobindo Ranitidine Caspules 150 mg
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class II · Moderate risk
DG Health Acid Reducer Ranitidine Tablets 150 mg
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Class II · Moderate risk
GSMS: Ranitidine Capsules 300 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
GSMS: Ranitidine Capsules 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Valganciclovir Hydrochloride for Oral Solution
Presence of foreign substance: Brown/black particles found during stability testing.
Class II · Moderate risk
Ranitidine Syrup
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Class III · Low risk
Cefdinir for Oral Suspension USP
Presence of Foreign substance: identified as a dead ant.
Class III · Low risk
Cefdinir for Oral Suspension USP
Presence of Foreign substance: identified as a dead ant.