Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-392-09; NDC CVS Health: 59779-540-09; NDC Family Wellness: 55319-852-09; NDC Good Neighbor Pharmacy: 46122-532-09; NDC HEB: 37808-507-09; NDC Health Mart: 49348-109-54; NDC Meijer: 41250-891-09; NDC Rite Aid: 11822-0852-3; NDC Shopko: 37012-852-09; NDC Sound Body: 50594-852-09; NDC Sunmark: 49348-109-54; NDC Up & Up: 11673-852-09; NDC Walgreens: 0363-0852-09
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
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