Sandoz is recalling lots of Ranitidine Hydrochloride Capsules 150mg and 300mg after it was confirmed that the product contains the probable carcinogen N-nitrosodimethylamine (NDMA). The recall includes all quantities in the US that are within expiry.
The affected products are packaged in 30, 60, and 500 count bottles and were manufactured between April 2017 to March 2018, with lot numbers HD1862, HP9438, HP9439, HP9440, HC9440, HD1865, HP9441, JK7994, JK8659, HD8625, HD9275, HU2207, HX6676, and HX6677.
At this time, the Company has not received any adverse event reports related to use of the recalled product. Consumers should contact their physician if they experience any problems that may be related to use of this product.
Ranitidine is prescribed for the treatment of active duodenal or benign gastric ulcer; maintenance of healing of duodenal or gastric ulcer; pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome and systemic mastocytosis); GERD; erosive esophagitis; and for maintenance of healing of erosive esophagitis.
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