FDA-Drug2022-02-02Class II
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
VIONA PHARMACEUTICALS INC
Hazard
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Sold states
Product was distributed to 17 wholesalers who further distributed the product to 85 locations.
Affected count
23,8416/100 count bottles
Manufactured in
20 Commerce Dr Ste 340, Cranford, NJ, United States
Products
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0392-2022Don't want to check this manually?
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