- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionNDMA (Nitrosodimethylamine) impurity
- Company Name:
- Denton Pharma, Inc. dba Northwind Pharmaceuticals
- Brand Name:
- Product Description:
Product DescriptionRanitidine Tablets 150mg and 300mg
Denton Pharma, Inc. dba Northwind Pharmaceuticals, an affiliate of Northwind Pharmaceuticals, LLC (“Northwind”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300mg, to the consumer level. The recall is in response to the manufacturer’s recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, which were repackaged by Denton Pharma, Inc. dba Northwind Pharmaceuticals. To date, Northwind has not received any reports of adverse events that have been confirmed to be directly related to 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 typically found in water and foods, including meats, dairy products and vegetables.
The Ranitidine Tablets, USP, distributed by Northwind are prescription oral products. Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.
The Ranitidine Tablets, USP, subject to the recall can be identified by the NDC number on the product label. The following NDCs of Ranitidine Tablets, USP, 150 mg and 300 mg, are included in this recall:
|Ranitidine Tablets, USP 150mg||70934-017-04
|Ranitidine Tablets, USP 300mg||70934-287-15
The affected Ranitidine Tablets were distributed directly to Northwind Pharmaceuticals, LLC and Crosswind Pharmacy.
The 150mg products product are packaged in unit of use bottle packs of 4’s, 20’s, 24’s, 30’s, and 90’s, whereas, the 300mg product are packaged in unit of use bottle packs of 15’s and 90’s. Photos are attached below.
Northwind is notifying its direct customers with a recall notification letter and is arranging for return of all recalled product. Anyone with an existing inventory of the product should quarantine the recalled lot immediately. Northwind is committed to product and consumer safety. It will continue to fully cooperate with the FDA as the agency evaluates ranitidine products for the presence of NDMA above established limits and formulates guidance for ranitidine manufacturers. As a further precautionary measure, Northwind ceased distribution of its Ranitidine products in the United States while the manufacturer continues its efforts to test and investigate in cooperation with the FDA.
Customers who purchased the impacted product directly from Northwind can call Northwind at 1-800-722-0772 Monday – Friday, 9:00 am – 5:00 pm, EST to arrange for product return.
Consumers who have Ranitidine Tablets, USP subject to this recall should immediately discontinue use, discard remaining product and consult with their physician or healthcare provider about treatment options.
Consumers who would like to report any adverse reactions or quality problems experienced as a result of their use of this product, or have questions regarding the use of Ranitidine Tablets, USP can contact Northwind at 1-800-722-0772 Monday – Friday, 9:00 am – 5:00 pm, EST.
Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.
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.
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