The Recall Desk
ModerateFDA (Drugs)·D-761-2014·Announced 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.

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 specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity rating involving potential contamination without confirmed harm.

Plain-English summary

Novartis Consumer Health is recalling specific lots of NeoCitran Extra Strength Non-Drowsy Cold & Sinus powder packets and Theraflu Daytime Severe Cold powder packets. The recall is being conducted because the products may contain foreign substances.

The affected products include NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets in Natural Source Lemon flavor, 10-count single dose pouches per carton, manufactured by Novartis Consumer Health Canada, Inc. The recall also includes Theraflu Daytime Severe Cold powder packets in Natural Lemon flavor, 6-count packets per carton, manufactured by Novartis Consumer Health, Inc. These products were 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 description, consumers should stop using it and follow the instructions provided by the recalling firm for disposal or return.

The recalled product

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
Manufacturer
Novartis Consumer Health
Category
Drug — Cold and Sinus Medicine
Hazard

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 (4)

  • Lot #: 10116030
  • Exp 6/30/2013. Korea product: 10112972
  • Exp 5/31/2013 and 10116032
  • Exp 7/31/2013.

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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