Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Heartburn & Stomach Medication Recalls
Recalls of acid reducers and stomach drugs - the class behind the ranitidine (Zantac) nitrosamine recalls.
211 recalls in this category, newest first.
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
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
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.
Class II · Moderate risk
Maximum Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
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