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

Recall Number: D-0392-2016

Firm: Geritrex Corp

Classification: Class II

Status: Terminated

Report Date: 20151209

Initiation Date: 20151027

Termination Date: 20180611

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

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