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
Reason for recall: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Recall initiated: 20151027
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated