FDA-Drug2020-11-04Class II
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
RemedyRepack Inc.
Hazard
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Sold states
Product was distributed to one customer in PA.
Affected count
79/30 count blister cards
Manufactured in
625 Kolter Dr Ste 4, N/A, Indiana, PA, United States
Products
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0050-2021Don't want to check this manually?
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