Carbo-O-Philic 40 Gel 40% — Class II drug recall D-0391-2016
Terminated recall by Geritrex Corp, reported 2015-12-09, distributed nationwide. Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbr
| Recall number | D-0391-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Geritrex Corp, Mount Vernon, NY, United States |
| Recall initiated | 2015-10-27 |
| Classified | 2015-11-27 |
| Reported by FDA | 2015-12-09 |
| Terminated | 2018-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 1,032 tubes |
| Reason classes | labeling, unapproved product |
| NDC | 54162-0016-15 |
| Lot numbers | 1502078, 1504139 |
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 for recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0391-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.