The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-210-2013·Announced 2013-03-27

Novartis Recalls Nasal Spray Due to Illegible Lot and Expiration Dates

Novartis Consumer Health is recalling 4 way Nasal Decongestant Menthol 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 indicates the product is not likely to cause adverse health consequences. The hazard is limited to packaging/labeling legibility.

Plain-English summary

Novartis Consumer Health, Inc. is recalling 4 way Nasal Decongestant Menthol Nasal Spray, an over-the-counter product containing phenylephrine hydrochloride 1%. The recall covers 1/2-fl. oz. and 1-fl. oz. bottles distributed nationwide and in Panama.

The recall was initiated because the lot number and/or expiration date on the product may be illegible. This labeling issue prevents consumers from verifying the specific lot and expiration date of the product.

Consumers with this product should check the lot number and expiration date against the specific codes listed in the official recall notice. If the product matches the recalled lots, consumers should stop using it and contact Novartis Consumer Health for instructions on return or disposal.

The recalled product

Product
4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2087-05) b) 1-fl. oz. bottles (NDC 0067-2087-01), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
Manufacturer
Novartis Consumer Health
Category
Drug — Over-the-Counter 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) 10120598
  • Exp 7/13
  • 10127563
  • Exp 11/13
  • b) 10107920
  • 10108362
  • 10108363
  • 10108364
  • 10109881
  • 10110017
  • 10110018
  • 10110019
  • 10110020
  • 10120730
  • 10120731
  • 10120732
  • 10120733
  • 10120734
  • 10120735
  • 10120736

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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