FDA Drug recall D-0391-2016
Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Ver…
- FDA Drug
- Class II
- terminated
- Published 2015-12-09
On 2015-12-09 the FDA classified a Class II recall of Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Ver… by Geritrex, citing marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0391-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-27 |
| Published | 2015-12-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Geritrex |
| Distribution | US |
Product
Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Vernon, NY 10550, NDC 54162-016-15
Reason
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Identifiers
| code_info | Lot # 1502078, 1504139 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0391-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.