FDA recall D-0392-2016

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-10-27

Report date

2015-12-09

Termination date

2018-06-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mount Vernon, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0392-2016