American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP 150 mg, 100 Count Unit Dose Blisters Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity
Summary
Risk Statement: NDMA is classified as a probable human carcinogen, a substance that can cause cancer, based on laboratory testing. American Health Packaging has not received any reports of adverse events that have been confirmed to be directly related to this recall. American Health Packaging has arranged for return of all recalled products to lnmar Pharmaceuticals Services. Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or e-mail at DrugSafety@amneal.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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