D-0390-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 9, 2015
- Initiation Date
- October 27, 2015
- Termination Date
- June 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,948 tubes: 3 oz(8,832), 7 oz(1,116)
Product Description
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 for Recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Distribution Pattern
Nationwide
Code Information
Lot #: a)1502156, 1507104 b)1503039, 1507001