Recall: D-0636-2017

Class III - Minor Violations

Class IIIClassification

2017-03-20Initiated

TerminatedStatus

G & W Laboratories, Inc.Firm

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.

Reason

Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.

Distribution

Nationwide in the USA and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.