Another recall has been issued for a generic version of a popular heartburn drug best known as Zantac due to the presence of a potentially cancer-causing impurity. It's the latest in several such recalls since September.
Aurobindo Pharma USA, Inc. is recalling 37 lots of Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL to the consumer level and one lot of Ranitidine Tablets 150mg to the retail level. They may contain Nitrosodimethylamine (NDMA).
This link provides a list of the medications, National Drug Codes (NDC), batch numbers and expiration dates.
Patients who are prescribed to take these drugs are urged to continue taking them. A doctor or pharmacist can advise alternate treatment options.
Aurobindo Pharma says it has not received any reports of adverse effects related to this recall.
Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA at:
- 1-866-850-2876 Option 2
- pvg@aurobindousa.com
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.
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 first recall for ranitidine was issued Sept. 23.
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.