Class II · Moderate risk
Ranitidine 150 mg tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
FDA Drug Recalls
75 recalls, newest first
Class II · Moderate risk
Ranitidine 150 mg tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10…
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Class II · Moderate risk
AVKARE Ranitidine Tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
AVKARE Ranitidine Tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Oral Solution
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
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
Ranitidine Syrup
CGMP Deviations: Presence of NDMA impurity detected in product.
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.
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.