FDA (Drugs) recall action 65490

Novartis Consumer Health recalled 16 products on 2014-01-29

The FDA (Drugs) publishes a recall like this one as 16 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 16 pages.

Products: 16
Announced: 2014-01-29
Critical: 0
Units: 12,058,590

Why these products were recalled

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–16 of 16

ModerateFDA (Drugs)··2014-01-29
Novartis Recalls Theraflu Severe Cold & Cough Powder Packets for Foreign Substances
Novartis Consumer Health is recalling Theraflu Severe Cold & Cough powder packets because they may contain foreign substances. The recall covers 917,400 cartons distributed in the US and internationally.
Product
Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol & Green Tea flavors and Nighttime formula (acetaminophen 650 mg, diphenhydramine h
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0 states
HighFDA (Drugs)··2014-01-29
Novartis Recalls Theraflu Powder Packets Due to Foreign Substance Presence
Novartis is recalling Theraflu and related cold medicine powder packets because they may contain foreign substances. The recall affects products distributed in the US, Canada, Mexico, and other countries.
Product
Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, labeled as a) Theraflu Sinus & Cold (NDC 006
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0 states
ModerateFDA (Drugs)··2014-01-29
Novartis Recalls NeoCitran Extra Strength Powder Packets Due to Foreign Substances
Novartis Consumer Health is recalling NeoCitran Extra Strength powder packets because they may contain foreign substances. The products were distributed nationwide and internationally.
Product
NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 20mg, chlorpheniramine maleate 4 mg, ascorbic acid 5 mg) powder packets, Soothing Lemon flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada In
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0 states
ModerateFDA (Drugs)··2014-01-29
Novartis Recalls Theraflu Exte Powder Packets Due to Foreign Substances
Novartis Consumer Health is recalling Theraflu Exte powder packets because they may contain foreign substances. The recall covers products distributed in the U.S. and several international markets.
Product
Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812881) and b) 10-count packets per carton (UPC 7 501124 814595), Distribut
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0 states
SevereFDA (Drugs)··2014-01-29
Novartis Recalls Theraflu Flu and Chest Congestion Powder Packets
Novartis Consumer Health is recalling Theraflu Flu & Chest Congestion powder packets because they may contain foreign substances.
Product
Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-0483-06, UPC 3 0043-0483-06 1.
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0 states
ModerateFDA (Drugs)··2014-01-29
Novartis Recalls NeoCitran Cold and Flu Powder Packets Due to Foreign Substances
Novartis Consumer Health is recalling NeoCitran Extra Strength Cold & Flu powder packets because they may contain foreign substances.
Product
NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga , ON, UPC 0 58478 0510
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0 states
ModerateFDA (Drugs)··2014-01-29
Novartis Recalls Theraflu Cold and Cough Powder Packets
Novartis is recalling Theraflu Daytime Severe Cold & Cough powder packets and NeoCitran products due to the potential presence of foreign substances.
Product
Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Berry Infused with Menthol & Green Tea flavors, 6-count packets per carton, , Distributed by: Novartis Consumer Health, Inc., Parsip
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0 states
ModerateFDA (Drugs)··2014-01-29
Theraflu Cold Powder Recalled for Potential Foreign Substances
Novartis Consumer Health is recalling Theraflu Multi-Symptom Severe Cold powder packets because they may contain foreign substances.
Product
THERAFLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL)
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Distribution
0 states
ModerateFDA (Drugs)··2014-01-29
Novartis Recalls NeoCitran DM Cough and Cold Powder Packets
Novartis is recalling NeoCitran DM Cough & Cold powder packets because they may contain foreign substances. The products were distributed in the U.S., Canada, and other countries.
Product
NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478
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0 states
ModerateFDA (Drugs)··2014-01-29
Novartis Recalls Theraflu MAX-D Powder Packets Due to Foreign Substances
Novartis Consumer Health is recalling Theraflu MAX-D and NeoCitran powder packets because they may contain foreign substances.
Product
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
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0 states
HighFDA (Drugs)··2014-01-29
Novartis Recalls NeoCitran Powder Packets Due to Foreign Substances
Novartis Consumer Health is recalling specific lots of NeoCitran powder packets because they may contain foreign substances. The products were distributed in the US, Canada, Mexico, and other countries.
Product
NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg) powder packets, Natural Source Cherry flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON
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0 states
ModerateFDA (Drugs)··2014-01-29
Novartis Recalls Cold and Sinus Powder Packets Due to Foreign Substances
Novartis is recalling NeoCitran and Theraflu cold and sinus powder packets because they may contain foreign substances.
Product
NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05703 3. Also
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0 states
HighFDA (Drugs)··2014-01-29
Theraflu Nighttime Severe Cold & Cough Powder Packets Recalled for Foreign Substances
Novartis Consumer Health is recalling Theraflu Nighttime Severe Cold & Cough powder packets because they may contain foreign substances.
Product
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
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0 states
HighFDA (Drugs)··2014-01-29
Novartis Recalls Theraflu Flu and Sore Throat Powder Packets
Novartis is recalling Theraflu Flu & Sore Throat powder packets because they may contain foreign substances. The recall affects 1.6 million cartons distributed in the US and internationally.
Product
Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Apple Cinnamon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7916-06
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0 states
ModerateFDA (Drugs)··2014-01-29
Novartis Recalls Theraflu Cold and Flu Powder Packets Due to Foreign Substances
Novartis Consumer Health is recalling specific lots of Theraflu Cold and Flu powder packets because they may contain foreign substances. The recall affects products distributed in the U.S., Mexico, Russia, Korea, Panama, China, and Canada.
Product
Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berries flavor, 10-count packets per box, UPC 4 607045 191760. (Russian product and Former Soviet Union product)
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0 states
ModerateFDA (Drugs)··2014-01-29
Theraflu Sugar-Free Nighttime Severe Cold & Cough Powder Packets Recalled for Foreign Substances
Novartis Consumer Health is recalling Theraflu Sugar-Free Nighttime Severe Cold & Cough powder packets because they may contain foreign substances.
Product
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 07054-0
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0 states