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.
FDA Drug Recalls
14,450 recalls · Class II, newest first
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.
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
Regular Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Regular Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Regular Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Regular Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Regular Strength Acid Reducer
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II · Moderate risk Terminated
Alprazolam Tablets
Reason Presence of Foreign Substance
Class II · Moderate risk Ongoing
Zantac 75 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Zantac 150 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Regular Strength Zantac 75 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Ongoing
Regular Strength Zantac 75 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.