4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b) 1-fl. oz. bottles (NDC 0067-2086-01), c) 1.25-fl. oz. bottles (NDC 0067-2086-15), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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, 10108371, 10108372, 10108373, 10108374, 10110027, 10110028, 10110029, 10110030, 10110031, 10110032, 10110033, 10115803, 10115804, 10115805, 10115806, 10115807, 10115809, 10115810, 10115812, 10115813, 10115814, 10115815, 10120728, 10120737, 10120738, 10120739, 10120740, 10120741, 10120742, 10120743, 10120744, 10120745, 10120746, 10120747, 10120748, 10120749, 10120750, 10120751, 10120752, 10121325, 10127542, 10127543, 10127544, 10127545, 10127546, 10127547, 10127548, 10127549, 10127550, Exp 3/13 to 10/13, c) 10116175, 10117996, 10117997, 10117998, 10117999, 10127535, 10127536, 10127537, 10127538, 10127539, 10127540, and 10127541, Exp 9/13 to 10/13.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Novartis Consumer Health
Reason for Recall:
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b) 1-fl. oz. bottles (NDC 0067-2086-01), c) 1.25-fl. oz. bottles (NDC 0067-2086-15), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.

Product Codes/Lot Numbers:

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, 10108371, 10108372, 10108373, 10108374, 10110027, 10110028, 10110029, 10110030, 10110031, 10110032, 10110033, 10115803, 10115804, 10115805, 10115806, 10115807, 10115809, 10115810, 10115812, 10115813, 10115814, 10115815, 10120728, 10120737, 10120738, 10120739, 10120740, 10120741, 10120742, 10120743, 10120744, 10120745, 10120746, 10120747, 10120748, 10120749, 10120750, 10120751, 10120752, 10121325, 10127542, 10127543, 10127544, 10127545, 10127546, 10127547, 10127548, 10127549, 10127550, Exp 3/13 to 10/13, c) 10116175, 10117996, 10117997, 10117998, 10117999, 10127535, 10127536, 10127537, 10127538, 10127539, 10127540, and 10127541, Exp 9/13 to 10/13.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-209-2013

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