FDA-Drug2022-01-19Class II
Metformin 750 mg Extended Release NDC # 70518-2920-00
RemedyRepack Inc.
Hazard
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Sold states
Product was distributed to one direct account in PA.
Affected count
56 Blister Cards
Manufactured in
625 Kolter Dr Ste 4, N/A, Indiana, PA, United States
Products
Metformin 750 mg Extended Release NDC # 70518-2920-00
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0366-2022Don't want to check this manually?
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