Home / Recalls / G & W Laboratories, Inc. / D-0250-2018

D-0250-2018 Class III Terminated

Recalled by G & W Laboratories, Inc. — South Plainfield, NJ

Recall Details

Product Type
Drugs
Report Date
February 14, 2018
Initiation Date
January 19, 2018
Termination Date
February 3, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
142,236 tubes

Product Description

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 for Recall

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

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

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

Other recalls by G & W Laboratories, Inc.

  • D-0945-2017 Class III — G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0 (June 2, 2017)
  • D-0636-2017 Class III — Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15 (March 20, 2017)
  • D-0519-2017 Class III — Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator (February 28, 2017)
  • D-0501-2017 Class II — Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxe (February 7, 2017)
  • D-391-2014 Class III — G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 6 (September 30, 2013)