The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-762-2014·Announced 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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 involving potential contamination without confirmed harm.

Plain-English summary

Novartis Consumer Health is recalling specific lots of Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor. The recall is being conducted because the products may contain foreign substances.

The affected products are packaged in 6-count and 10-count cartons. Specific lot numbers and expiration dates are listed in the recall details. The products were distributed nationwide in the United States, as well as in Mexico, Russia, Korea, Panama, China, and Canada.

Consumers should stop using the recalled products and return them to the place of purchase for a refund or contact Novartis Consumer Health for further instructions.

The recalled product

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)…
Manufacturer
Novartis Consumer Health
Category
Drug — Cold and Flu
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 (7)

  • Lot #: a) 10119730
  • Exp 9/30/2013
  • b) 10115568
  • 10115570
  • Exp 6/30/2013
  • 10119728
  • Exp 9/30/2013.

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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