FDA-Drug2020-01-29Class II
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
RemedyRepack Inc.
Hazard
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Sold states
Product was distributed to two facilities in CA and NY.
Affected count
4,486 tablets
Manufactured in
625 Kolter Dr Ste 4, Indiana, PA, United States
Products
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0798-2020Don't want to check this manually?
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