INDIANAPOLIS (WTHR) — For the third time in the past week, a recall has been issued for the generic version of a popular heartburn and ulcer drug that is best known as Zantac.
Amneal Pharmaceuticals on Tuesday voluntarily recalled dozens of lots of Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL.
The drugs may contain N-Nitrosodimethylamine (NDMA) at amounts above levels established by the Food and Drug Administration. NDMA is a nitrosamine. The FDA says nitrosamines can be found naturally in water, meats, dairy products and vegetables, but NDMA is also a probable human carcinogen.
This link of the recall notice contains lists for both the product names and counts, but also their lot numbers and expiration dates. Consumers who have it are advised to stop using it and to call call Stericycle at 866-918-8768, Monday – Friday, 8:00 am – 5:00 pm EST for more information.
Amneal says there have been no adverse effects reported as a result of this recall. If an adverse reaction is experienced, consumers are advised to call their doctor.
This is the third recall for Ranitidine since last Wednesday. Aurobindo Pharma USA issued a recall for capsules and syrup on Nov. 6. American Health Packaging issued a recall last Friday for Ranitidine Syrup which was distributed to wholesalers for use in hospital settings.
There have been nine recalls for Ranitidine since Sept. 23.
The FDA released a statement Nov. 1 that states its testing has found levels of NDMA in ranitidine "are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats." But, the agency says it still must test ranitidine in the human body to fully understand if it forms NDMA.
The same impurity is one of three nitrosamines that have been found in some blood pressure medications, leading to dozens of recalls since July 2018.