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
Check against the official notice below — it lists the full affected range.
G & W Laboratories, Inc. is recalling G & W Clobetasol Propionate Ointment 0.05% in four different tube sizes (15 g, 30 g, 45 g, and 60 g) distributed nationwide. The recall affects 145,284 tubes across multiple lot numbers with expiration dates ranging from August 2017 through July 2018. The product is being recalled because certain lots failed quality specifications for Clobetasol Related Compound A, a known impurity that is a degradation product.
The recall record does not specify a remedy or action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Nationwide Quantity: 145284 tubes Lot/code info: 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
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.