G & W Laboratories, Inc.: 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, Manufactur

Is my product affected?

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.

• Brand CICLOPIROX OLAMINE

Check against the official notice below — it lists the full affected range.

What happened

G & W Laboratories, Inc. is recalling Ciclopirox Olamine Cream USP, 0.77%, distributed nationwide in the USA and Puerto Rico. The recall affects 230,700 tubes across three package sizes: 15 g tubes (NDC 0713-0638-15), 30 g tubes (NDC 0713-0638-31), and 90 g tubes (NDC 0713-0638-18). The reason for the recall is that certain product lots were packaged with an out-of-date package insert.

The affected lots and expiration dates vary by package size. For 15 g tubes, the affected lots are 63800090 (Exp 04/17), 63800095 (Exp 11/17), 1000573 (Exp 02/18), and 1002560 (Exp 06/18). For 30 g tubes, the affected lots are 63800090 (Exp 04/17), 63800092 (Exp 07/17), 63800093 (Exp 08/17), 63800095 (Exp 11/17), 1000574 (Exp 02/18), and 1001772 (Exp 05/18). For 90 g tubes, the affected lots are 63800089 (Exp 03/17), 63800091 (Exp 07/17), 63800094 (Exp 08/17), 1000842 (Exp 01/18), 1000966 (Exp 03/18), 1001771 (Exp 05/18), and 1002562 (Exp 06/18). The source record does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.

Details from the source

Reason for recall: Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert. Distribution: Nationwide in the USA and Puerto Rico Quantity: 230,700 tubes Lot/code info: Lot #: a) 63800090, Exp 04/17; 63800095, Exp 11/17; 1000573, Exp 02/18; 1002560, Exp 06/18; b) 63800090, Exp 04/17; 63800092, Exp 07/17; 63800093, Exp 08/17; 63800095, Exp 11/17; 1000574, Exp 02/18; 1001772, Exp 05/18; c) 63800089, Exp 03/17; 63800091, Exp 07/17; 63800094, Exp 08/17; 1000842, Exp 01/18; 1000966, Exp 03/18; 1001771, Exp 05/18; 1002562, Exp 06/18.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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