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SafetyAlerts
February 6, 2002

G&W Laboratories Has Recalled Pain Relieving Rub

South Plainfield, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said that G&W Laboratories Inc. has recalled Pain Relieving Rub, Greaseless, Stainless Analgesic Cream, (Menthol 10%, Methyl Salicylate 15%), 4 oz net weight tube. This is a white, smooth homogeneous cream that contains 10% (w/w) Menthol and 15% Methyl Salicylate as its active ingredients.

PRODUCT
Pain Relieving Rub, Greaseless, Stainless Analgesic Cream, (Menthol 10%, Methyl Salicylate 15%), 4 oz net weight tube.This is a white, smooth homogeneous cream that contains 10% (w/w) Menthol and 15% Methyl Salicylate as its active ingredients.

The recalled lots, 0045-3 and 0095-3, were packaged into one of the four following PVC tubes:
1) G & W generic tube labeled in part "Greaseless / Stainless
*** Pain relieving rub *** Analgesic Cream *** For Muscle Aches and Arthritis Pain"
2) HY-TOP tube labeled in part "NDC 61795-28304 ***
Penetrating *** Muscle Rub *** Greaseless / Stainless Analgesic Cream"
3) Shop Rite tube labeled in part "Greaseless / Stainless
ANALGESIC CREAM *** Pain relieveing rub *** For muscle aches and arthritis pain"
4) H-E-B Pharmacy tube labeled in part "Muscle Rub ***
Greaseless Pain Relieving Cream *** For Muscle Aches & Arthritis Pain"

The recalled lots were packaged into one of the five following boxes:
1) G & W box labeled in part "Greaseless/Stainless Analgesic Cream *** Pain relieving rub *** For Muscle Aches and Arthritis Pain *** Arthritis, Backaches, Muscle Aches". The Universal Product Code (UPC) number on the bottom of the box is 0713-0283-04
2) HY-TOP box labeled in part "NDC 61795-28304 *** Penetrating *** Muscle Rub *** Greaseless / Stainless Analgesic Cream". The UPC number on the bottom of the box is 50700-05861 .
3) Shop Rite box labeled in part "Greaseless / Stainless
Analgesic Cream *** Pain relieving rub *** for muscle aches and arthritis pain". The UPC number on the bottom of the box is 41190-21816
.
4) H-E-B Pharmacy box labeled in part "Muscle Rub ***
Greaseless Pain Relieving Cream *** For Muscle Aches & Arthritis Pain". The UPC number on the bottom of the box is 41220-52909 .
5) 1st Choice Box labeled in part "Greaseless/Stainless
Analgesic Cream *** Pain relieving rub *** For muscle aches and arthritis pain". The UPC number on the bottom of the box is 39131-28304

Each tube was placed in its corresponding box (ie. HY-TOP tube in the HY-TOP box and H-E-B tube in the H-E-B box) except that the G & W generic tube was placed in both the G & W and 1st Choice box.
Recall # D-102-2.

CODE
Lot Numbers: 0045-3 Exp. 3/2002;
0095-3 Exp. 4/2002.

RECALLING FIRM/MANUFACTURER
G&W Laboratories Inc., South Plainfield, NJ, by letter on Nov. 8, 2001. Firm initiated recall is ongoing.

REASON
Subpotent: active ingredient Methyl Salicylate.

VOLUME OF PRODUCT IN COMMERCE
Lot 0045-3 -- 7632 pieces;
Lot 0095-3 -- 11,136 pieces.

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.