Drug Safety Alerts

Marksans Metformin Hydrochloride Extended-Release 500mg and 750mg Tablets Expanded Consumer-Level Recall

10/05/2020

On October 5, 2020, the United States Food and Drug Administration (FDA) published a notice regarding Marksans Pharma Limited’s expansion of its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg, manufactured by Marksans and distributed by Time-Cap Labs, to the consumer level. This recall was issued because Marksans observed that N-Nitrosodimethylamine (NDMA) content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day.

A complete list of the affected products and lot numbers is provided here.

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 found in water and foods, including meats, dairy products and vegetables. Marksans Pharma Limited has advised that as of the date of its announcement, it has not received any reports of adverse events that have been related to this recall.

Marksans advises that consumers taking these recalled product lots of Metformin ER Tablets should continue taking it until a doctor or pharmacist gives them 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 health care professional. Marksans further advises that 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.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.

Please note: These products are not carried by the CVS Caremark® Mail Service Pharmacies.

For more information about this recall, please contact Time-Cap Labs Inc. at 1-877-376-4271 or visit https://3ecda060-a745-4adb-942f-71c8368cfdf1.filesusr.com/ugd/62361f_8045273dc4794a1bb9cf2842cd199805.pdf.

You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.