D-0392-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 9, 2015
- Initiation Date
- October 27, 2015
- Termination Date
- June 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 844,704 suppositories
Product Description
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 Pattern
Nationwide
Code Information
Lot #: 1310001, 13J04, 1310167, 1311013, 1312008, 1401055, 13S02, 14A05, 1402061, 14C01, 14C05, 14C06, 14E02, 1405081, 1406107, 1407062, 14096751, 14096752, 14096753, 15026752, 15026752, 15046752, 15066752, 15066753