The Recall Desk
HighFDA (Drugs)·D-758-2014·Announced 2014-01-29

Novartis Recalls NeoCitran Powder Packets Due to Foreign Substances

Novartis Consumer Health is recalling specific lots of NeoCitran powder packets because they may contain foreign substances. The products were distributed in the US, Canada, Mexico, and other countries.

What this means for you

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 potential foreign substances in a drug product where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Novartis Consumer Health is voluntarily recalling certain lots of NeoCitran powder packets. The products are being recalled because they may contain foreign substances. The affected products include NeoCitran Ultra Strength Total Flu 7 Symptom Relief and NeoCitran Extra Strength Sore Throat & Cough, both in Natural Source Cherry flavor. Each carton contains 10 single-dose pouches.

The recall covers specific lot numbers with expiration dates ranging from June 2013 to April 2014. The 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 they have the affected products, they should stop using them and contact Novartis Consumer Health for a refund or further instructions.

The recalled product

Product
NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg) powder packets, Natural Source Cherry flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON
Manufacturer
Novartis Consumer Health
Category
Drug — Over-the-Counter 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 (6)

  • Lot #: a) 10112236
  • Exp 4/30/2014 and 10122295
  • Exp 9/30/2014
  • b) 10093319
  • Exp 6/30/2013 and 10100417
  • 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 →

Related recalls

Same manufacturer · Novartis Consumer Health

See all →

Same hazard · foreign substance

See all →