December 17, 2003
Qualis Has Recalled Cold & Hot Therapy
Pain Relief Cream
The FDA has released the following information.
Cold & Hot Therapy Pain Relief Cream, Extra Strength (Methyl Salicylate 30%
and Menthol 10%) Net Weight 1.25 oz. (35.4g). Sold under other brands as: 1)
Brooks Pharmacy Cold and Hot Extra Strength Therapy Pain Relief Cream, Net
Weight 1.25 oz. (35.4g); 2) Pathmark Extra Strength Cold and Hot Therapy
Pain Relief Cream, Net Weight 1.25 oz. (35.4g); 3) Extra Strength Cold & Hot
pain relief cream, Net Wt. 3 oz. (85 g). Recall # D-075-4.
Code/Exp. date: 2H06A/August 2004; 2H29C/August 2004;
2113B/September 2004; 2117B/October 2004; 2K07B/November 2004; 3A14A/January
2005; 3B26B/ February 2005; 3C24D/March 2005; 3D22A/April 2005; 3E19B/March
2005; 3F19E/June 2005; 3G09C/July 2005; 3G16A/July 2005; 3H25D/August 2005;
Qualis Inc., Des Moines, IA, by telephone on October 16, 2003. Firm
initiated recall is ongoing.
Subpotent; (Methyl Salicylate) 12-month stability.
VOLUME OF PRODUCT IN COMMERCE
11,868 (1.25-oz.) & 35,724 (3-oz.) tubes.