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G & W Laboratories Recalls
6 recalls on record · January 8, 2014 to February 14, 2018 · Drugs
Recalls by year
14
17
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 14, 2018DrugsFDA
G & W Laboratories, Inc. recalls 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
Hazard: Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
July 12, 2017DrugsFDA
G & W Laboratories, Inc. recalls 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,
Hazard: 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.
April 12, 2017DrugsFDA
G & W Laboratories, Inc. recalls 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
Hazard: Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
March 22, 2017DrugsFDA
G & W Laboratories, Inc. recalls Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL
Hazard: CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
March 8, 2017DrugsFDA
G & W Laboratories, Inc. recalls Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W L
Hazard: Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
January 8, 2014DrugsFDA
G & W Laboratories Inc recalls G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manuf
Hazard: Failed Content Uniformity Specifications; at the 18 month time point.