KANSAS CITY, MO (KTAL/KMSS) — A company has expanded its recall of a diabetes medication due to an ingredient that may cause cancer.
According to the U.S. Food and Drug Administration, Nostrum Laboratories, Inc. is voluntarily recalling one lot of the Metformin HCl extended release tablets, USP 750 mg, generic equivalent to Glucophage Tablets.
Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit https://t.co/qL7MyEmtzQ pic.twitter.com/CgLoPbiDZp— U.S. FDA Recalls (@FDArecalls) January 5, 2021
The tablets have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued Sept. 2020.
This is an expansion of the recall initially announced in Nov. 2020.
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.
To date, Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall.
The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01.
The product, which can be identified as an off-white oblong tablet debossed with “NM7”, was distributed Nationwide to wholesalers:
- Consumers should consult a healthcare professional to obtain a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their healthcare professional.
- Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.
- Consumers with medical questions regarding this recall can contact Nostrum Laboratories, Inc. Medical Affairs at (816) 308-4941 or email firstname.lastname@example.org Monday through Friday from 8 a.m. until 5 p.m. CST.
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 (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 (800) FDA-0178