The Recall Desk
SevereFDA (Drugs)·D-755-2014·Announced 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.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when specific injury or hospitalization reports are not explicitly detailed but the classification indicates a temporary or medically reversible adverse health consequence.

Plain-English summary

Novartis Consumer Health is recalling specific lots of Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor. The recall involves 398,208 cartons of the 6-count packets. The affected lots are 10115134 (Exp 5/31/2013), 10119862 (Exp 7/31/2013), and 10122276 and 10124325 (Exp 10/31/2013).

The products are being recalled because they may contain foreign substances. The agency has classified this as a Class II recall. The products were distributed nationwide and in Mexico, Russia, Korea, Panama, China, and Canada.

Consumers should check their cartons for the lot numbers and expiration dates listed above. If the product matches the recalled description, consumers should stop using it and contact Novartis Consumer Health for instructions on return or disposal.

The recalled product

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.
Manufacturer
Novartis Consumer Health
Category
Drug — OTC Cold and Flu
Hazard
Affected units
398,208

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 #: 10115134
  • Exp 5/31/2013
  • 10119862
  • Exp 7/31/2013
  • 10122276
  • 10124325
  • Exp 10/31/2013.

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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