Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
Recall Number: D-0392-2022
Firm: VIONA PHARMACEUTICALS INC
Classification: Class II
Status: Terminated
Report Date: 20220202
Initiation Date: 20211227
Termination Date: 20230920
Reason for Recall
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Product Description
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01