Class II · Moderate risk
Cell Salts Combination 6X Tablets
CGMP Deviations: products were not manufactured under current good manufacturing practices.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
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 II · Moderate risk
LETS GEL KIT Convenience Pack
Microbial contamination of non-sterile product.
Class II · Moderate risk
Potassium Phosphate
Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
Class II · Moderate risk
Lannett Ranitidine Syrup
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Maximum Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk
Maximum Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk
Maximum Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk
Maximum Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.