DACO Alerta sobre Recall FDA MedWatch – Metformin Hydrochloride Extended-Release Tablets USP, 500 mg by Marksans

7 de junio de 2020


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A MedWatch Safety Alert was added to the FDA Recalls web page.

TOPIC: Metformin Hydrochloride Extended-Release Tablets USP, 500 mg by Marksans: Recall – Due to the Detection of N-Nitrosodimethylamine

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: Marksans Pharma is recalling Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, lot # XP9004. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96ng/day. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

Marksans Pharma has not received any reports of adverse events related to this recall to date.

Foto MetMorfin Etiqueta

BACKGROUND: Metformin Hydrochloride Extended-Release Tablets USP, 500 mg is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.

RECOMMENDATION: Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

· Complete and submit the report online.

· Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

 

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