Class II · Moderate risk Terminated
Cell Salts Combination 6X Tablets
Reason CGMP Deviations: products were not manufactured under current good manufacturing practices.
FDA Drug Recalls
11,815 recalls · Class II, newest first
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.
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 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 II · Moderate risk Terminated
Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only…
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Maximum Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.