Sandoz Recalls Ranitidine for Gastrointestinal Indications Due to Contamination

Sandoz Recalls Ranitidine for Gastrointestinal Indications Due to Contamination

Sandoz Inc. is voluntarily recalling all quantities and lots within expiry of Ranitidine hydrochloride capsules because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA.

Ranitidine hydrochloride capsules are indicated for the treatment of duodenal ulcer, benign ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable. 

Relevant to workers’ comp, patients taking opioid pain medications may experience gastrointestinal side effects, requiring a gastrointestinal agent and potentially to leading a concurrent prescription of ranitidine hydrochloride.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

Fourteen lots of ranitidine hydrochloride capsules are being recalled, ranging from 30 count to 500 count bottles, manufactured from April 19, 2017 through March 20, 2019, with expiration dates ranging from April 30, 2020 through March 31, 2021. 

Sandoz is notifying customers and distributors of the recall. 

For further information, read the FDA Recall Notice.