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), an…

Recall date

March 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0636-2017

FDA classification

Class III

Brand / firm

G & W Laboratories, Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.