G & W Laboratories, Inc. recalls Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and
Recalled April 12, 2017 · FDA recall D-0636-2017 · G & W Laboratories
Hazard
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert. · FDA Class III
Units
230,700 tubes
Sold at
Nationwide in the USA and Puerto Rico
Description
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Product
Ciclopirox Olamine Cream USP, 0.77%, 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 by: G&W Laboratories, Inc., South Plainfeld, NJ 07080.
Manufacturer(s)
G & W Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →