The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-748-2014·Announced 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.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves the presence of foreign substances in a drug product, which poses a risk of harm even without reported injuries.

Plain-English summary

Novartis Consumer Health is recalling specific lots of Theraflu Flu & Sore Throat powder packets (Natural Apple Cinnamon flavor) and NeoCitran Extra Strength Cold & Flu powder packets (Apple Cinnamon flavor). The recall involves 1,614,564 cartons of the product. The agency has classified this as a Class II recall.

The products are being recalled because they may contain foreign substances. The affected products were distributed nationwide in the United States, as well as in Mexico, Russia, Korea, Panama, China, and Canada. Specific lot numbers and expiration dates are listed in the recall notice, including lots expiring between May 2013 and October 2013.

Consumers should check their cartons for the affected lot numbers and expiration dates. If the product matches the description, consumers should stop using it and contact Novartis Consumer Health for a refund or further instructions.

The recalled product

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…
Manufacturer
Novartis Consumer Health
Category
Drug — Over-the-Counter Medication
Hazard
Affected units
1,614,564

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 (19)

  • Lot #: 10115121
  • 10115832
  • Exp 5/31/2013
  • 10119854
  • 10119856
  • Exp 7/31/2013
  • 10122257
  • 8/31/2013
  • 10124286
  • 10124289
  • 10124292
  • Exp 9/30/2013
  • 10128103
  • 10128105
  • 10128108
  • 10128110
  • Exp 10/31/2013. NeoCitran Cold & Flu: 10115118
  • Exp 5/31/2013 and 10122252
  • 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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