FDA-Drug2023-04-12Class II
Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), 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) 399 bottles, b)445 bottles
Manufactured in
625 Kolter Dr Ste 4, Indiana, PA, United States
Products
Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottles (NDC 70518-0375-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0501-2023Don't want to check this manually?
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