Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalls of acid reducers and stomach drugs - the class behind the ranitidine (Zantac) nitrosamine recalls.
211 recalls in this category, newest first.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Failed Impurities/Degradation Specifications.
Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Lack of Processing Controls.
Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
Lack of Processing Controls.
Failed Stability Specifications
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