VIONA PHARMACEUTICALS INC recalls Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Recalled February 2, 2022 · FDA recall D-0392-2022 · VIONA PHARMACEUTICALS
Hazard
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. · FDA Class II
Units
23,8416/100 count bottles
Sold at
Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
Description
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Product
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Manufacturer(s)
VIONA PHARMACEUTICALS INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →