GRx HiCort 25 Suppositories recalled over labeling errors

Recall date

October 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Geritrex Corp recalls GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation…

Recall number

D-0392-2016

FDA classification

Class II

Brand / firm

Geritrex Corp

Sold / distributed

Nationwide

Why it was recalled

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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