Drug 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
D-0391-2016
Product summary
- Firm
- Geritrex Corp
- Event
- Event 72509
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,032 tubes
- Official record key
drug-enforcement:D-0391-2016
Official wording
Reason: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Code information: Lot # 1502078, 1504139
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
misbranded