FDA-Drug2015-12-09Class II
GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY 10550, NDC 54162-015-12
Geritrex Corp
Hazard
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Sold states
Nationwide
Affected count
844,704 suppositories
Manufactured in
144 Kingsbridge Road East, Mount Vernon, NY, United States
Products
GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY 10550, NDC 54162-015-12
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0392-2016Don't want to check this manually?
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