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 Plainfield, 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%, a prescription antifungal medication, due to discoloration in some units. The product is supposed to be white to off-white in color but may display intermittent yellow discoloration. The recall affects 142,236 tubes distributed nationwide in the USA and Puerto Rico across three package sizes: 15 g tubes, 30 g tubes, and 90 g tubes. Multiple lot numbers are affected, with expiration dates ranging from June 2018 through July 2019.

Affected lot numbers include: for 15 g tubes, lots 1002896 (Exp 09/18), 1005797 (Exp 05/19), and 1006100 (Exp 07/19); for 30 g tubes, lots 1002561 (Exp 06/18), 1002897 (Exp 09/18), 1005798 (Exp 05/19), and 1006101 (Exp 07/19); and for 90 g tubes, lots 1002898 (Exp 10/18), 1004283 (Exp 12/18), 1005837 (Exp 05/19), 1006321, and 1006322 (both Exp 07/19). The source document does not specify a remedy or instructions for affected consumers.

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

Hazard

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

Details from the source

Reason for recall: 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 Quantity: 142,236 tubes Lot/code info: Lot #: a) 1002896, Exp 09/18; 1005797, Exp 05/19; 1006100, Exp 07/19; b) 1002561, Exp 06/18; 1002897, Exp 09/18; 1005798, Exp 05/19; 1006101, Exp 07/19; c) 1002898, Exp 10/18; 1004283, Exp 12/18; 1005837, Exp 05/19; 1006321, 1006322, Exp 07/19

Source

Official record: FDA (Drug enforcement) ↗

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

Related recalls

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All FDA (Drug enforcement) recalls