The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-759-2014·Announced 2014-01-29

Novartis Recalls NeoCitran Cold and Flu Powder Packets Due to Foreign Substances

Novartis Consumer Health is recalling NeoCitran Extra Strength Cold & Flu powder packets because they may contain foreign substances.

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 hazard is the presence of foreign substances without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Novartis Consumer Health is voluntarily recalling specific lots of NeoCitran Extra Strength Cold & Flu powder packets. The recall is being conducted because the products may contain foreign substances.

The affected products are 10-count single dose pouches in Natural Source Lemon flavor. The recall includes products 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 official recall notice.

Consumers who have purchased these products should check their lot numbers against the recall list. If the product matches the recalled lots, consumers should stop using it and contact the manufacturer for instructions on how to return the product or obtain a refund.

The recalled product

Product
NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga , ON, UPC 0 58478…
Manufacturer
Novartis Consumer Health
Category
Drug — Cold and Flu Medication
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 (20)

  • Lot #: 10113888
  • Exp 5/31/2013
  • 10118944
  • Exp 6/30/2013
  • 10120024
  • Exp 9/30/2013
  • 10124381
  • Exp 10/31/2013. Russia product: 10112623
  • 10112625
  • 10112627
  • 10112629
  • 10112631
  • 10112633
  • 10116051
  • 10116053
  • 10116055
  • 10116057
  • 10116059
  • 10116061
  • 10117302

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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