- A popular generic medication used in the treatment of type 2 diabetes is being recalled by the manufacturer.
- The product may contain elevated levels of a human carcinogen, and the amounts are above an acceptable level.
- Anyone taking the drug should contact their doctor to arrange for a replacement of their medication before stopping the use of the recalled drug.
In a new recall bulletin posted by the FDA, Nostrum Laboratories, Inc., is recalling one lot of a popular type 2 diabetes medication. The company’s generic Metformin HCl Extended-Release Tablets in 750mg doses have been found to contain an elevated level of a probably human carcinogen called NDMA.
The impurities are potentially dangerous as they could encourage the growth of cancers, and various drugs are regularly tested by the FDA in order to determine how much of the naturally-occurring contaminant is present. In this case, the levels of the impurity were too high to be acceptable, forcing the recall.
NDMA (N-nitrosodimethylamine) is an organic compound that can be found in many products. It is considered to be a probable human carcinogen, meaning that it is likely to promote cancer, based on laboratory tests. It is often found in manufactured drugs, though companies can still sell their medications if the levels are beneath a certain threshold.
It’s not uncommon to see a drug company initiate a recall due to elevated levels of this compound, and it is often discovered after testing by a regulatory agency. In this case, a single lot of the drug has been marked for recall. The product specifics are as follows:
- NDC: 29033-056-01
- Lot Number: MET200501
- Expiration Date: 07/2022
The recall bulletin from the company reads, in part:
Nostrum Laboratories, Inc. is notifying its distributors by letter and is arranging for return of all recalled products. Pharmacies that have Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) which is being recalled should return to place of purchase. 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.
Obviously, it’s not a good idea to spontaneously stop taking your diabetes medication, so it’s incredibly important to speak with your doctor or other healthcare providers to arrange for a replacement of the medication if the pills you’re taking fall under the recalled lot number.
You can find additional information, including the contact number for the company if you need more information, on the official recall bulletin. If you suspect you have a bottle of the recalled medication, contact your doctor promptly and inform them of the situation. They should guide you through the next steps and get you set up with a new prescription.