Reported Feb 14, 2018 · Terminated
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31);…
G & W Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: G & W Laboratories, Inc. · 200 Helen St · South Plainfield, NJ · 07080-3800
Is this the product you have?
Ciclopirox Olamine Cream USP0.77%packaged in a) 15 g tubes (NDC 0713-0638-15)b) 30 g tubes (NDC 0713-0638-31)and c) 90 g tubes (NDC 0713-0638-18)Rx Only
- Manufactured byG&W Laboratories, Inc., South Plainfield, NJ 07080
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 1002896, Exp 09/18; 1005797, Exp 05/19; 1006100, Exp 07/19 2 1002561, Exp 06/18; 1002897, Exp 09/18; 1005798, Exp 05/19; 1006101, Exp 07/19 3 1002898, Exp 10/18; 1004283, Exp 12/18; 1005837, Exp 05/19; 1006321, 1006322, Exp 07/19 - Amount recalled
- 142,236 tubes
Where it was sold
- Nationwide
- PR
Why it was recalled
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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 G & W Laboratories, Inc. 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.