Geritrex Corp recalls GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation
Recalled December 9, 2015 · FDA recall D-0392-2016 · Geritrex
Hazard
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. · FDA Class II
Units
844,704 suppositories
Sold at
Nationwide
Description
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Product
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
Manufacturer(s)
Geritrex Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →