D-0391-2016 Class II Terminated
FDA drug recall D-0391-2016 was initiated by Geritrex Corp on October 27, 2015 and is designated Class II. Reason for recall: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded. The recall status is terminated (terminated June 11, 2018). Affected quantity: 1,032 tubes.
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
- 1,032 tubes
Product Description
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.
Distribution Pattern
Nationwide
Code Information
Lot # 1502078, 1504139