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SafetyAlerts
February 9, 2001

TheraPatch Vapor nose & chin Cough Suppressant Recalled

Edina, MN (SafetyAlerts) - The Food and Drug Administration (FDA) said today that LecTec Corporation  is recalling its TheraPatch Vapor nose & chin Cough Suppressant because of pouch seal failures (opening along top, sides and/or bottom).

This is the first public notice of this Class III recall issued by FDA.

PRODUCT
TheraPatch Vapor nose & chin Cough Suppressant containing 14 strips; NDC# 51747-012-01; active ingredients: Camphor 4.7% and Menthol 2.6%; TheraPatch Vapor chest Cough Suppressant containing 7 patches; NDC# 51747-005-01; active ingredients: Camphor 4.7% and Menthol 2.6%; Triaminic Vapor Patch, Menthol Scent containing 6 patches per carton; NDC# 0067-0209-06; active ingredients: Camphor 4.7% and Menthol 2.6%; product is labeled as being distributed by Novartis Consumer Health,Inc., Summit, NJ.

The products are described on the TheraPatch labels as "Ointment on a breathable cloth patch" or "Ointment On A Breathable Adhesive Cloth Patch".

Recall #D-087-089-1.

CODE:
All lots manufactured during the last 18 months.

MANUFACTURER:
LecTec Corporation , Edina, MN.

RECALLED BY:
Manufacturer, by letters, dated November 20, 2000. Firm-initiated recall ongoing.

DISTRIBUTION:
Nationwide.

QUANTITY:
6043 cases of 24 retail packages per case of TheraPatch Vapor Chest;1810 cases of 24 retail packages per case of TheraPatch Vapor nose/chin;329 cases of 36 retail packages per case of TheraPatch Vapor nose/chin.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Notice of this product warning was sent via email to SafetyAlerts subscribers February 9, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.