Recall: D-0250-2018

Class III - Minor Violations

Class IIIClassification

2018-01-19Initiated

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 Plainfield, NJ 07080.

Reason

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

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.