The Recall Desk
ModerateFDA (Drugs)·D-753-2014·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Novartis Consumer Health is recalling specific lots of Theraflu MAX-D Severe Cold & Flu powder packets and NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief powder packets. The recall is being conducted because the products may contain foreign substances.

The affected products include Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powder packets in Natural Citrus flavor, and NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief powder packets in Soothing Lemon flavor. The recall covers 868,104 cartons distributed nationwide in the United States, as well as in Mexico, Russia, Korea, Panama, China, and Canada.

Consumers should check their cartons for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact Novartis Consumer Health for further instructions.

The recalled product

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
Manufacturer
Novartis Consumer Health
Category
Drug — Cold & Flu Medication
Hazard
Affected units
868,104

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot #: 10089568
  • Exp 5/31/2013
  • 10093324
  • 10094745
  • 10097626
  • 10097627
  • Exp 7/31/2013
  • 10098588
  • 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.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 16 recalled by Novartis Consumer Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 16 products in this recall →

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