FDAFDA · Food and drugs·Recall number D-754-2014
Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6318-06, UPC 3 0043-6318-06 0.
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 #: 10116040, Exp 6/30/2013; 10119871, Exp 7/31/2013; 10122275, Exp 9/30/2013.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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