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December 17,  2003

Qualis Has Recalled Cold & Hot Therapy Pain Relief Cream

(SafetyAlerts) - The FDA has released the following information.

PRODUCT
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
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; 3126A/September 2005.

RECALLING FIRM/MANUFACTURER
Qualis Inc., Des Moines, IA, by telephone on October 16, 2003. Firm initiated recall is ongoing.

REASON
Subpotent; (Methyl Salicylate) 12-month stability.

VOLUME OF PRODUCT IN COMMERCE
11,868 (1.25-oz.) & 35,724 (3-oz.) tubes.

DISTRIBUTION
Nationwide
.

 
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.