FDAFDA · Food and drugs·Recall number D-756-2014
Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon Infused with Chamomille & White Tea flavors, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6256-06, UPC 3 0043-6256-06. Also packaged under foreign label: NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, diphenhydramine hydrochloride 25 mg, Soothing Honey Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., UPC 0 58478 10594 9.
Published January 29, 2014 · Recall initiated: June 18, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Novartis Consumer Health
- Distributor
- Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
- Lot
- Lot #: 1011525, 10115834, Exp 5/31/2013; 10116012, 10116043, 10116045, 10116047, 10116049, 10117462, 10118936 Exp 6/30/2013; 10118683, 10118685, 10118934, 10118938, Exp 7/31/2013; 10122278, 10122280, 1012282, Exp 8/31/2013; 10124331, 10124333, 10124335, 10125908, Exp 9/30/2013; 10125923, 10126909, 10126911, 10127023, 10127026, Exp 10/31/2013. NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief: 10116036, Exp 6/30/2013 and 10122273, Exp 9/30/2013.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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