The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-209-2013·Announced 2013-03-27

Novartis Recalls 4 Way Nasal Spray Due to Illegible Labeling

Novartis Consumer Health is recalling 4 Way Nasal Spray because lot numbers and expiration dates may be illegible.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is limited to packaging and labeling legibility.

Plain-English summary

Novartis Consumer Health is voluntarily recalling 4 Way Nasal Decongestant Fast Acting Nasal Spray. The recall is due to labeling issues where the lot number and/or expiration date may be illegible.

The affected product is an over-the-counter nasal spray containing phenylephrine hydrochloride 1%. It is distributed in 1/2-fl. oz., 1-fl. oz., and 1.25-fl. oz. bottles. The recall covers units distributed nationwide and in Panama.

Consumers with affected products should stop using them and contact Novartis Consumer Health for a refund or replacement. The specific lot numbers and expiration dates are listed in the official recall notice.

The recalled product

Product
4 WAY (PHENYLEPHRINE HYDROCHLORIDE)
Brand
4 WAY
Manufacturer
Novartis Consumer Health
Category
Drug — OTC Nasal Spray
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 #: a) 10108375
  • 10108376
  • 10110025
  • 10110026
  • 10115487
  • 10115488
  • 10120594
  • 10120595
  • 10120596
  • 10120597
  • 10120753
  • 10120754
  • 10120755
  • 10127564
  • and 10127567
  • Exp 4/13 to 11/13
  • b) 10107916
  • 10108368
  • 10108369
  • 10108370

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

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