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  4. Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product
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COMPANY ANNOUNCEMENT

Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product

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
Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
Company Name:
Sandoz Inc.
Brand Name:
Brand Name(s)
Sandoz Inc.
Product Description:
Product Description
Ranitidine Hydrochloride Capsules

Company Announcement

Sandoz Inc. is voluntarily recalling all quantities and lots within expiryof Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules. To date, Sandoz 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 is an oral product, 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. 

The affected Sandoz Ranitidine includes 30 count, 60 count and 500 count bottles in the following lots:

Product Name NDC Number Lot Nbr. Expiration Date Date of Manufacture
RANITIDINE 150mg Capsules 500 count 0781-2855-05 HD1862 4/30/2020 4/19/2017
RANITIDINE 150mg Capsules 500 count 0781-2855-05 HP9438 9/30/2020 9/5/2017
RANITIDINE 150mg Capsules 500 count 0781-2855-05 HP9439 9/30/2020 9/6/2017
RANITIDINE 150mg Capsules 500 count 0781-2855-05 HP9440 9/30/2020 9/5/2017
RANITIDINE 150mg Capsules 60 count 0781-2855-60 HC9266 4/30/2020 4/19/2017
RANITIDINE 150mg Capsules 60 count 0781-2855-60 HD1865 4/30/2020 4/19/2017
RANITIDINE 150mg Capsules 60 count 0781-2855-60 HP9441 9/30/2020 9/6/2017
RANITIDINE 150mg Capsules 60 count 0781-2855-60 JK7994 8/31/2021 8/7/2018
RANITIDINE 150mg Capsules 60 count 0781-2855-60 JK8659 8/31/2021 8/7/2018
RANITIDINE 300mg Capsules 30 count 0781-2865-31 HD8625 4/30/2020 4/27/2017
RANITIDINE 300mg Capsules 30 count 0781-2865-31 HD9275 4/30/2020 4/27/2017
RANITIDINE 300mg Capsules 30 count 0781-2865-31 HU2207 8/31/2020 8/24/2017
RANITIDINE 300mg Capsules 30 count 0781-2865-31 HX6676 3/31/2021 3/20/2018
RANITIDINE 300mg Capsules 30 count 0781-2865-31 HX6677 3/31/2021 3/20/2018

The product can be identified by the NDC number and lot number provided above. Sandoz Ranitidine Hydrochloride Capsules were distributed nationwide to wholesalers.

Sandoz will be notifying its distributors and customers via overnight mail and via the Sandoz web site, and will arrange for return of all recalled products. Wholesalers (direct customers) will be asked to immediately stop distribution and return any stock to Sandoz, and contact the retail pharmacies in their group to do the same. Pharmacies will be asked to immediately stop dispensing Sandoz Ranitidine Hydrochloride Capsules and return remaining stock to Sandoz by contacting Stericycle to request a recall packet. Consumers are asked to continue taking their medication and speak to their physician or pharmacist on alternate healthcare treatment options.

Consumers with questions regarding this recall can contact Sandoz at 1-800-525-8747 option # between 8:30am – 5:00pm Monday – Friday EST or www.us.sandoz.com for more information. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. This information and package photos are available at  

https://www.us.sandoz.com/patients-customers/product-safety-notices
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Company Contact Information

Consumers:
Sandoz
1-800-525-8747
Media:
Leslie Pott
+1 609 627 5287
Leslie.pott@sandoz.com