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UPMC Cole

Friday, November 8, 2019

RECALLS

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 1 lot of Ranitidine Tablets 150mg to the retail level and 37 lots of Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL to the consumer level due to the detection of NDMA (Nitrosodimethylamine) Impurity in the finished product. The impurity detected is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

Ranitidine is a competitive, reversible inhibitor of the action of histamine at the histamine H2 receptors found in gastric parietal cells. This results in decreased gastric acid secretion and gastric volume, and reduced hydrogen ion concentration. Uses are:

Relieves heartburn associated with acid indigestion and sour stomach.
Prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages. 

Patients who prescribed or are taking Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL should continue taking their medication.  Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

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