FDA-Drug2017-04-12Class III
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.
G & W Laboratories, Inc.
Hazard
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
230,700 tubes
Manufactured in
111 Coolidge St, N/A, South Plainfield, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0636-2017Don't want to check this manually?
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