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FDAMarch 20, 2017drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.

What to do

FDA enforcement status: Terminated

Brands named

g w laboratories

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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