Home / Recalls / G & W Laboratories, Inc. / D-0945-2017

D-0945-2017 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
July 12, 2017
Initiation Date
June 2, 2017
Termination Date
May 9, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
145284 tubes

Product Description

G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g tube (NDC 0713-0656-37), d) 60 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080

Reason for Recall

Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.

Distribution Pattern

Nationwide

Code Information

Lot #: a) 1001090, Exp 8/ 17; 1002881, Exp 2/18; b) 1001086, Exp 8/ 17; 1001154, Exp 11/ 17; 1001156, Exp 9/17; 1002882, Exp 2/18, 1004564, Exp 7/18; c) 1001155, Exp 9/17; 1004572, Exp 7/18; d) 1001158, Exp 9/17; 1001159, Exp 10/17; 1002884, Exp 4/18

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-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)