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

January 19, 2018

Source

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

Recall number

D-0250-2018

FDA classification

Class III

Brand / firm

G & W Laboratories, Inc.

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.

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 Plainfield, NJ 07080.