A MedWatch Safety Alert was added to the FDA Recalls webpage.
Ranitidine Tablets, 150mg and 300mg, and Ranitidine Syrup (Oral Solution), 15 mg/mL by Amneal Pharmaceuticals: Recall - Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity
AUDIENCE: Consumer, Patient, Health Professional, Pharmacy
ISSUE: Ranitidine Tablets, USP, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Amneal Pharmaceuticals, has not received any reports of adverse events that have been confirmed to be directly related to this recall.For a complete list of recalled products, please read the recall announcement.
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