FDAFDA · Food and drugs·Recall number 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 only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550
Published December 9, 2015 · Recall initiated: October 27, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Geritrex Corp
- Distributor
- Nationwide
- Lot
- Lot #: a)1502156, 1507104 b)1503039, 1507001
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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