Drug 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
D-0390-2016
Product summary
- Firm
- Geritrex Corp
- Event
- Event 72509
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,948 tubes: 3 oz(8,832), 7 oz(1,116)
- Official record key
drug-enforcement:D-0390-2016
Official wording
Reason: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Code information: Lot #: a)1502156, 1507104 b)1503039, 1507001
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
misbranded