Reported Apr 12, 2017 · 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. · 111 Coolidge St · South Plainfield, NJ · 07080-3895
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 Plainfeld, NJ 07080
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 63800090, Exp 04/17; 63800095, Exp 11/17; 1000573, Exp 02/18; 1002560, Exp 06/18 2 63800090, Exp 04/17; 63800092, Exp 07/17; 63800093, Exp 08/17; 63800095, Exp 11/17; 1000574, Exp 02/18; 1001772, Exp 05/18 3 63800089, Exp 03/17; 63800091, Exp 07/17; 63800094, Exp 08/17; 1000842, Exp 01/18; 1000966, Exp 03/18; 1001771, Exp 05/18; 1002562, Exp 06/18. - Amount recalled
- 230,700 tubes
Where it was sold
- Nationwide
- PR
Why it was recalled
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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