Medications & Supplements/Prescription Drugs

Denton Pharma, Inc.: Ranitidine Tablets Recalled Due to Presence of NDMA Impurity

Agency Publication Date: January 20, 2020

Summary

Denton Pharma, Inc. is recalling 1,808 bottles of Ranitidine Tablets (150 mg and 300 mg), a medication commonly used to treat heartburn and stomach ulcers, which were repackaged by Northwind Pharmaceuticals. The recall was initiated because testing detected the presence of N-nitrosodimethylamine (NDMA), an impurity that exceeds acceptable safety levels. These prescription-only medications were distributed nationwide in various bottle sizes ranging from 4-count to 90-count containers. Consumers who have these products should stop using them and consult with their healthcare provider regarding alternative treatments.

Risk

NDMA is classified as a probable human carcinogen (a substance that could cause cancer). The impurity was detected in the product during testing, indicating that the tablets do not meet the required safety and quality standards for human consumption.

What You Should Do

Check your medication bottles for Ranitidine Tablets, USP 150 mg or 300 mg, repackaged by Northwind Pharmaceuticals.
Identify 150 mg tablets by checking for NDC numbers 70934-017-04, 70934-017-20, 70934-017-24, 70934-017-30, or 70934-017-90 and lot numbers: N102851902, D102851801, N102851901, N102851903, N102851906, N102851904, N102851905, C102851901, C102851902, C102851903, C102851904, C102851905, C102851906, or C102851907.
Identify 300 mg tablets by checking for NDC numbers 70934-287-15 or 70934-287-90 and lot numbers: N106851901, N106851902, C106851901, C106851902, C106851903, C106851904, or C106851905.
If you have an affected product, contact your healthcare provider or pharmacist immediately to discuss a replacement prescription or alternative treatment options.
Return any unused product to the pharmacy where it was purchased for a refund and contact Denton Pharma, Inc. for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider and return product to pharmacy.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Ranitidine Tablets, USP 150 mg (4, 20, 24, 30, and 90 count bottles)

Model:

NDC 70934-017-04

NDC 70934-017-20

NDC 70934-017-24

NDC 70934-017-30

NDC 70934-017-90

Lot Numbers:

N102851902 (Exp. 04/30/2021)

D102851801 (Exp. 04/2021)

N102851901 (Exp. 11/30/2021)

N102851903 (Exp. 12/31/2021)

N102851906 (Exp. 03/31/2022)

N102851904 (Exp. 02/28/2022)

N102851905 (Exp. 12/31/2021)

C102851901 (Exp. 11/30/2021)

C102851902 (Exp. 11/30/2021)

C102851903 (Exp. 11/30/2021)

C102851904 (Exp. 05/31/2021)

C102851905 (Exp. 02/28/2022)

C102851906 (Exp. 02/28/2022)

C102851907 (Exp. 03/31/2022)

Date Ranges: 04/30/2021, 04/2021, 11/30/2021, 12/31/2021, 03/31/2022, 02/28/2022, 05/31/2021

Product: Ranitidine Tablets, USP 300 mg (15 and 90 count bottles)

Model:

NDC 70934-287-15

NDC 70934-287-90

Lot Numbers:

N106851901 (Exp. 11/30/2021)

N106851902 (Exp. 10/31/2021)

C106851901 (Exp. 11/30/2021)

C106851902 (Exp. 10/31/2021)

C106851903 (Exp. 02/28/2022)

C106851904 (Exp. 11/30/2021)

C106851905 (Exp. 05/31/2022)

Date Ranges: 11/30/2021, 10/31/2021, 02/28/2022, 05/31/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84657

Status: Resolved

Manufacturer: Denton Pharma, Inc.

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 2 products (1,341 bottles; 467 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication bottles for Ranitidine Tablets, USP 150 mg or 300 mg, repackaged by Northwind Pharmaceuticals.

Identify 150 mg tablets by checking for NDC numbers 70934-017-04, 70934-017-20, 70934-017-24, 70934-017-30, or 70934-017-90 and lot numbers: N102851902, D102851801, N102851901, N102851903, N102851906, N102851904, N102851905, C102851901, C102851902, C102851903, C102851904, C102851905, C102851906, or C102851907.

Identify 300 mg tablets by checking for NDC numbers 70934-287-15 or 70934-287-90 and lot numbers: N106851901, N106851902, C106851901, C106851902, C106851903, C106851904, or C106851905.

If you have an affected product, contact your healthcare provider or pharmacist immediately to discuss a replacement prescription or alternative treatment options.

Return any unused product to the pharmacy where it was purchased for a refund and contact Denton Pharma, Inc. for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Ranitidine Tablets, USP 150 mg (4, 20, 24, 30, and 90 count bottles)

Model:

NDC 70934-017-04

NDC 70934-017-20

NDC 70934-017-24

NDC 70934-017-30

NDC 70934-017-90

Lot Numbers:

N102851902 (Exp. 04/30/2021)

D102851801 (Exp. 04/2021)

N102851901 (Exp. 11/30/2021)

N102851903 (Exp. 12/31/2021)

N102851906 (Exp. 03/31/2022)

N102851904 (Exp. 02/28/2022)

N102851905 (Exp. 12/31/2021)

C102851901 (Exp. 11/30/2021)

C102851902 (Exp. 11/30/2021)

C102851903 (Exp. 11/30/2021)

C102851904 (Exp. 05/31/2021)

C102851905 (Exp. 02/28/2022)

C102851906 (Exp. 02/28/2022)

C102851907 (Exp. 03/31/2022)

Date Ranges: 04/30/2021, 04/2021, 11/30/2021, 12/31/2021, 03/31/2022, 02/28/2022, 05/31/2021

Product: Ranitidine Tablets, USP 300 mg (15 and 90 count bottles)

Model:

NDC 70934-287-15

NDC 70934-287-90

Lot Numbers:

N106851901 (Exp. 11/30/2021)

N106851902 (Exp. 10/31/2021)

C106851901 (Exp. 11/30/2021)

C106851902 (Exp. 10/31/2021)

C106851903 (Exp. 02/28/2022)

C106851904 (Exp. 11/30/2021)

C106851905 (Exp. 05/31/2022)

Date Ranges: 11/30/2021, 10/31/2021, 02/28/2022, 05/31/2022