FDA Drug recall D-0390-2016
Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use o…
- 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 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use o… 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-0390-2016 |
| 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 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550
Reason
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Identifiers
| code_info | Lot #: a)1502156, 1507104 b)1503039, 1507001 |
|---|
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-0390-2016%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.