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
Reported: December 9, 2015 Initiated: October 27, 2015 #D-0391-2016
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.
Details
- Recalling Firm
- Geritrex Corp
- Units Affected
- 1,032 tubes
- Distribution
- Nationwide
- Location
- Mount Vernon, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Geritrex Corp. Units affected: 1,032 tubes.
Why was this product recalled? ▼
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 9, 2015. Severity: Moderate. Recall number: D-0391-2016.
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