Audience: Providers of Impacted Patients
Glenmark Pharmaceutical Inc. announced the voluntary recall of all unexpired lots of ranitidine tablets, 150 mg and 300 mg, to the consumer level. The recalled lots of ranitidine tablets 150 mg and 300 mg are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the FDA, based on FDA-validated tests. To date, Glenmark has not received any reports of adverse events that have been confirmed to be directly related to this recall.
A list of your patients who may have filled a prescription for ranitidine over the last four months is printed on the bottom of this notice. We have notified these patients of the ranitidine recall and advised them to contact you to discuss possible alternative medications to treat their health condition, or to contact Glenmark Drug Safety at 1-888-721-7115.
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