FDA-Drug2023-04-12Class II
Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
RemedyRepack Inc.
Hazard
cGMP Deviations
Sold states
RemedyRepack distributed product to consignees nationwide within the United States
Affected count
a) 147 bottles, b)70 bottles, c) 3 bottles
Manufactured in
625 Kolter Dr Ste 4, Indiana, PA, United States
Products
Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) and c)180-count bottles (NDC 70518-0405-02), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0493-2023Don't want to check this manually?
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