Home / Recalls / G & W Laboratories, Inc. / D-0636-2017

D-0636-2017 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
April 12, 2017
Initiation Date
March 20, 2017
Termination Date
February 14, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
230,700 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 Plainfeld, NJ 07080.

Reason for Recall

Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

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.

Other recalls by G & W Laboratories, Inc.

  • D-0250-2018 Class III — Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15 (January 19, 2018)
  • 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-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)