G & W Laboratories

6 recalls •

• Categories: Prescription Drugs

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.

Class I - Dangerous

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

Jan 19, 2018 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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.

Jun 2, 2017 Prescription Drugs Nationwide View Details →

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.

Class I - Dangerous

Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.

Mar 20, 2017 Prescription Drugs Nationwide View Details →

Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles (NDC 0472-0987-92), Rx Only, Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080; Distributed by: Actavis Mid Atlantic LLC, 1877 Kawai Road, Lincolnton, NC 28092.

Class I - Dangerous

CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.

Feb 28, 2017 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

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

Feb 7, 2017 Prescription Drugs View Details →

G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080

Class I - Dangerous

Failed Content Uniformity Specifications; at the 18 month time point.

Sep 30, 2013 Prescription Drugs Nationwide View Details →