FDAFDA · Food and drugs·Recall number D-753-2014
Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6427-06, UPC 3 0067-6427-06 5. Also packaged under foreign label: NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief powder packets, Soothing Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 10701 1.
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 #: 10089568, Exp 5/31/2013; 10093324, 10094745, 10097626, 10097627, Exp 7/31/2013; 10098588, Exp 9/30/2013. NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief : 10093316, Exp 7/31/2013; 10098591, Exp 9/30/2013; 10101027, Exp 10/31/2013; 10102623, Exp 11/30/2013; 10106813, Exp 1/31/2014; 10115844, Exp 6/30/2014; 10124363, Exp 9/30/2014.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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