- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason Description
May contain N-Nitrosodimethylamine (NDMA)
- Company Name:
- Novitium Pharma
- Brand Name:
- Product Description:
Ranitidine Hydrochloride Capsules 150 mg and 300 mg
Novitium Pharma LLC (Novitium) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules in the US to the consumer level. Ranitidine Hydrochloride Capsules are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. To date, Novitium has not received any reports of adverse events related to use of the product as part of this recall.
Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.
Ranitidine Hydrochloride Capsules are indicated for the treatment of duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable. The affected Ranitidine Hydrochloride Capsule can be identified by NDC numbers stated on the product label.
|Ranitidine Capsules 150mg||150 mg||Rx||60 ct bottle||70954-001-20|
|Ranitidine Capsules 150mg||150 mg||Rx||500 ct bottle||70954-001-40|
|Ranitidine Capsules 300mg||300 mg||Rx||30 ct bottle||70954-002-10|
|Ranitidine Capsules 300mg||300 mg||Rx||100 ct bottle||70954-002-40|