Recall: D-0392-2022

Class II - Potentially Harmful

Class IIClassification

2021-12-27Initiated

TerminatedStatus

VIONA PHARMACEUTICALS INCFirm

Product

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01

Reason

CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Distribution

Product was distributed to 17 wholesalers who further distributed the product to 85 locations.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.