June 2017 FDA Recall Clobetasol Propionate by G & W Laboratories, Inc.
D-0945-2017 - Failed impurities/degradation specifications

This Class III drug recall was voluntarily initiated by G & W Laboratories, Inc. on June 2, 2017 for the product Clobetasol Propionate. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0945-2017

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.
Initiated
06-02-2017
Reported
07-12-2017
Quantity
145284 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77401
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
G & W Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration 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

Affected Packages Involved in this Recall

0713-0656-15 Clobetasol Propionate
0713-0656-31 Clobetasol Propionate
0713-0656-37 Clobetasol Propionate
0713-0656-60 Clobetasol Propionate