Reported Jan 29, 2014 · Terminated
Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural…
Novartis Consumer Health
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Novartis Consumer Health · 10401 Hwy 6 · Lincoln, NE · 68517-9626
Is this the product you have?
Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by
5 of 5 products
| # | Product as published |
|---|---|
| 1 | Theraflu Sinus & Cold (NDC 0067-6319-06, UPC 3 0043-6319-06 |
| 2 | and |
| 3 | Theraflu Cold & Sore Throat (NDC 0067-6716-06, UPC 3 0043-0467-16 0). Also packaged under foreign labels: NeoCitran Cold & Flu powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05009 6; and Theraflu Exthegran powder packets, lemon flavor, packaged in |
| 4 | 6-count packets per carton (UPC 7 501124 812904) and |
| 5 | 10-count packets per carton (UPC 7 501124 814588), Distributed by Novartis Farmaceutica S.A. De C.V., Mexico |
- Lot codes and dates
Lot #: a) 10116014Exp 6/30/201310122246Exp 7/31/201310124322Exp 9/30/201310128122Exp 11/30/2013b) 10119852Exp 7/31/201310122249Exp 8/31/201310124321Exp 9/30/201310128118Exp 11/30/201310128120Exp 11/30/2013
- NeoCitran Cold & Flu
10115576Exp 6/30/201310122243Exp 8/31/2013 and 10124319Exp 9/30/2013Theraflu Exthegran 1011557910115572Exp 6/30/201310117549Exp 8/30/2013
- Amount recalled
- 1,140,564 cartons
This recall covers 16 products
The agency filed one notice per product. You are reading one of them; the other 15 are below.
3 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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