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  4. Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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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)
Novitium Pharma
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

Company Contact Information

Consumers:
Novitium, Navya Jaikumar
(609) 469-5920
info@novitiumpharma.com
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