October 9, 2019

Multiple Companies Recall Ranitidine Hydrochloride Due to Contamination

Back in September, Sandoz Inc. voluntarily recalled all quantities and lots within expiry of ranitidine hydrochloride capsules because of confirmed contamination with N-Nitrosodimethylamine (NDMA), a probable human carcinogen, 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 being prescribed ranitidine hydrochloride.

While this initial recall from Sandoz impacted 14 lots ranging from 30-500 count bottles, more recalls have since been initiated in October.

Sanofi has issued a recall for all Zantac OTC (ranitidine hydrochloride) in the U.S., Perrigo is recalling all ranitidine hydrochloride worldwide, and Dr. Reddy’s is recalling ranitidine hydrochloride nationwide. All of these recalls are based around similar concerns of contamination surrounding NDMA.

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