February 9, 2001TheraPatch Vapor nose & chin
Cough Suppressant Recalled
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.
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".
All lots manufactured during the last 18 months.
LecTec Corporation , Edina, MN.
Manufacturer, by letters, dated November 20, 2000. Firm-initiated recall ongoing.
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.
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