Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:

Recall Reason Description

May contain N-Nitrosodimethylamine (NDMA)

Company Name:
Novitium Pharma
Brand Name:

Brand Name(s)

Product Description:

Product Description

Ranitidine Hydrochloride Capsules 150 mg and 300 mg


Company Announcement

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. 

Description

Strength

Type

Pack Size

 

NDC

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