Reported Dec 9, 2015 · Terminated
Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex…
Geritrex Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Geritrex Corp · 144 Kingsbridge Road East · Mount Vernon, NY · 10550
Is this the product you have?
Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube.5 oz (15 g)Rx Only For topical use onlyDistributed byGeritrex Corporation 144Mount VernonNY 10550NDC 54162-016-15
- Lot codes and dates
Lot # 15020781504139
- Amount recalled
- 1,032 tubes
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Geritrex Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.