RemedyRepack Inc. recalls Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indi
Recalled November 4, 2020 · FDA recall D-0050-2021 · RemedyRepack
Hazard
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) · FDA Class II
Units
79/30 count blister cards
Sold at
Product was distributed to one customer in PA.
Description
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Product
Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA NDC 70518-2480-00
Manufacturer(s)
RemedyRepack Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →