Home / Recalls / G & W Laboratories, Inc. / D-0501-2017

D-0501-2017 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
March 8, 2017
Initiation Date
February 7, 2017
Termination Date
June 18, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3456 boxes

Product Description

Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W Laboratories Inc. South Plainfield, NJ 07080, Distributed by Iroko Pharmaceuticals, LLC Philadelphia, PA 19112, NDC 42211-0102-43

Reason for Recall

Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.

Distribution Pattern

Within United States

Code Information

Lot #: 017600011, Exp. Jan 2018, 0176000014, Exp. Aug 2018, 017600015, Exp. Sep 2018

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-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-391-2014 Class III — G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 6 (September 30, 2013)