Medications & Supplements/Prescription Drugs

Denton Pharma, Inc.: Metformin Extended-Release Tablets Recalled for NDMA Impurity

Agency Publication Date: November 3, 2020

Summary

Denton Pharma, Inc. is recalling various lots of Metformin Hydrochloride Extended-Release Tablets, USP in 500 mg and 750 mg strengths. This recall affects over 6,800 bottles of the 500 mg tablets and several hundred bottles of the 750 mg tablets. The recall was initiated because laboratory testing detected N-Nitrosodimethylamine (NDMA) impurity at levels that exceed the acceptable intake limit set by the manufacturer and the FDA. Consumers should check their prescription bottles to see if their medication is part of the affected lot numbers and expiration dates ranging from October 2020 through November 2021.

Risk

NDMA is classified as a probable human carcinogen. While it is a known environmental contaminant found in water and foods, exposure to levels above acceptable limits over a long period may increase the risk of cancer.

What You Should Do

Check your Metformin bottle for the following specific NDC numbers: 70934-334-30 (750 mg), 70934-309-30 (500 mg, 30-count), 70934-309-60 (500 mg, 60-count), 70934-309-90 (500 mg, 90-count), or 70934-309-98 (500 mg, 120-count).
Verify if your bottle matches affected lot numbers for 750 mg tablets (N107411901, N107411903, N107411904, N107411905, N107411906, N107411907, N107412001, N107412002, N107412004, N107412003) or 500 mg tablets (starting with N10705 or C10705).
Contact your healthcare provider or pharmacist immediately for guidance before you stop taking this medication. It is dangerous for patients with type 2 diabetes to stop taking metformin without an alternative treatment.
Return any unused medication from the affected lots to your pharmacy for a refund and to obtain a replacement prescription from a different manufacturer.
Contact Northwind Pharmaceuticals at the address 119 Creamery Rd, North Blenheim, NY 12131 for further instructions regarding this recall.
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

Drug recall refund and consultation

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

Affected Products

Product: Metformin Hydrochloride Extended-Release Tablets USP 750 mg (30 count bottle)

Model:

NDC 70934-334-30

Lot Numbers:

N107411901 (Exp 11/30/2020)

N107411903 (Exp 11/30/2020)

N107411904 (Exp 11/30/2020)

N107411905 (Exp 11/30/2020)

N107411906 (Exp 11/30/2020)

N107411907 (Exp 4/30/2021)

N107412001 (Exp 4/30/2021)

N107412002 (Exp 11/30/2021)

N107412004 (Exp 11/30/2021)

N107412003 (Exp 7/31/2021)

Date Ranges: Expiration 11/30/2020, Expiration 4/30/2021, Expiration 7/31/2021, Expiration 11/30/2021

Product: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg (30 count bottle)

Model:

NDC 70934-309-30

Lot Numbers:

N107051905 (Exp 10/31/2020)

N107052002 (Exp 9/30/2021)

N107052005 (Exp 9/30/2021)

Date Ranges: Expiration 10/31/2020, Expiration 9/30/2021

Product: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg (60 count bottle)

Model:

NDC 70934-309-60

Lot Numbers:

N107051907 (Exp 10/31/2020)

N107052001 (Exp 6/30/2021)

N107052010 (Exp 9/30/2021)

N107052008 (Exp 9/30/2021)

N107052004 (Exp 9/30/2021)

Date Ranges: Expiration 10/31/2020, Expiration 6/30/2021, Expiration 9/30/2021

Product: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg (90 count bottle)

Model:

NDC 70934-309-90

Lot Numbers:

C107051908 (Exp 10/31/2020)

C107052002 (Exp 6/30/2021)

C107051909 (Exp 6/30/2021)

C107052001 (Exp 12/31/2020)

C107052004 (Exp 9/30/2021)

N107052006 (Exp 9/30/2021)

N107052007 (Exp 9/30/2021)

N107052009 (Exp 9/30/2021)

N107052011 (Exp 9/30/2021)

N107052012 (Exp 9/30/2021)

Date Ranges: Expiration 10/31/2020, Expiration 12/31/2020, Expiration 6/30/2021, Expiration 9/30/2021

Product: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg (120 count bottle)

Model:

NDC 70934-309-98

Lot Numbers:

C107051907 (Exp 10/31/2020)

N107051904 (Exp 10/31/2020)

N107051906 (Exp 10/31/2020)

C107051910 (Exp 6/30/2021)

C107052003 (Exp 9/30/2021)

C107052005 (Exp 9/30/2021)

N107052003 (Exp 9/30/2021)

Date Ranges: Expiration 10/31/2020, Expiration 6/30/2021, Expiration 9/30/2021

Product Images

Metformin Hydrochloride Extended-Release Tablets, USP 500mg Pack size: 90 Tablets

Metformin Hydrochloride Extended-Release Tablets, USP 500mgPack size: 100 Tablets

Metformin Hydrochloride Extended-Release Tablets, USP 500mg Pack size: 500 Tablets

Metformin Hydrochloride Extended-Release Tablets, USP 500mg Pack size: 1000 Tablets

Metformin Hydrochloride Extended-Release Tablets, USP 750mg Pack size: 100 Tablets

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86593

Status: Active

Manufacturer: Denton Pharma, Inc.

Sold By: Northwind Pharmaceuticals; Time-Cap Labs, Inc.

Manufactured In: United States

Units Affected: a) 684; b) 432; c) 3668; d) 2029 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 · FDA Press Release · 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 Metformin bottle for the following specific NDC numbers: 70934-334-30 (750 mg), 70934-309-30 (500 mg, 30-count), 70934-309-60 (500 mg, 60-count), 70934-309-90 (500 mg, 90-count), or 70934-309-98 (500 mg, 120-count).

Verify if your bottle matches affected lot numbers for 750 mg tablets (N107411901, N107411903, N107411904, N107411905, N107411906, N107411907, N107412001, N107412002, N107412004, N107412003) or 500 mg tablets (starting with N10705 or C10705).

Contact your healthcare provider or pharmacist immediately for guidance before you stop taking this medication. It is dangerous for patients with type 2 diabetes to stop taking metformin without an alternative treatment.

Return any unused medication from the affected lots to your pharmacy for a refund and to obtain a replacement prescription from a different manufacturer.

Contact Northwind Pharmaceuticals at the address 119 Creamery Rd, North Blenheim, NY 12131 for further instructions regarding this recall.

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: Metformin Hydrochloride Extended-Release Tablets USP 750 mg (30 count bottle)

Model:

NDC 70934-334-30

Lot Numbers:

N107411901 (Exp 11/30/2020)

N107411903 (Exp 11/30/2020)

N107411904 (Exp 11/30/2020)

N107411905 (Exp 11/30/2020)

N107411906 (Exp 11/30/2020)

N107411907 (Exp 4/30/2021)

N107412001 (Exp 4/30/2021)

N107412002 (Exp 11/30/2021)

N107412004 (Exp 11/30/2021)

N107412003 (Exp 7/31/2021)

Date Ranges: Expiration 11/30/2020, Expiration 4/30/2021, Expiration 7/31/2021, Expiration 11/30/2021

Product: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg (30 count bottle)

Model:

NDC 70934-309-30

Lot Numbers:

N107051905 (Exp 10/31/2020)

N107052002 (Exp 9/30/2021)

N107052005 (Exp 9/30/2021)

Date Ranges: Expiration 10/31/2020, Expiration 9/30/2021

Product: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg (60 count bottle)

Model:

NDC 70934-309-60

Lot Numbers:

N107051907 (Exp 10/31/2020)

N107052001 (Exp 6/30/2021)

N107052010 (Exp 9/30/2021)

N107052008 (Exp 9/30/2021)

N107052004 (Exp 9/30/2021)

Date Ranges: Expiration 10/31/2020, Expiration 6/30/2021, Expiration 9/30/2021

Product: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg (90 count bottle)

Model:

NDC 70934-309-90

Lot Numbers:

C107051908 (Exp 10/31/2020)

C107052002 (Exp 6/30/2021)

C107051909 (Exp 6/30/2021)

C107052001 (Exp 12/31/2020)

C107052004 (Exp 9/30/2021)

N107052006 (Exp 9/30/2021)

N107052007 (Exp 9/30/2021)

N107052009 (Exp 9/30/2021)

N107052011 (Exp 9/30/2021)

N107052012 (Exp 9/30/2021)

Date Ranges: Expiration 10/31/2020, Expiration 12/31/2020, Expiration 6/30/2021, Expiration 9/30/2021

Product: Metformin Hydrochloride Extended-Release Tablets, USP 500 mg (120 count bottle)

Model:

NDC 70934-309-98

Lot Numbers:

C107051907 (Exp 10/31/2020)

N107051904 (Exp 10/31/2020)

N107051906 (Exp 10/31/2020)

C107051910 (Exp 6/30/2021)

C107052003 (Exp 9/30/2021)

C107052005 (Exp 9/30/2021)

N107052003 (Exp 9/30/2021)

Date Ranges: Expiration 10/31/2020, Expiration 6/30/2021, Expiration 9/30/2021