Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c)…
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
100 FDA recalls mention Ranitidine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ranitidine.
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Reason CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Reason CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Reason CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
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