Drug 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
D-0392-2016
Product summary
- Firm
- Geritrex Corp
- Event
- Event 72509
- Status
- Terminated
- Classification
- Class II
- Quantity
- 844,704 suppositories
- Official record key
drug-enforcement:D-0392-2016
Official wording
Reason: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
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
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
misbranded