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.
Check against the official notice below — it lists the full affected range.
Novartis Consumer Health is recalling4 Way Nasal Decongestant Fast Acting Nasal Spray in three bottle sizes (1/2-fl. oz., 1-fl. oz., and 1.25-fl. oz.) distributed nationwide and in Panama. The recall affects over 1.8 million bottles across multiple lot numbers with expiration dates ranging from March 2013 to November 2013. The reason for the recall is that the lot number and/or expiration date on the labeling may be illegible.
The source document does not specify what consumers should do regarding this recalled product.
Written by software from the official notice below. Not reviewed by a lawyer.
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Reason for recall: Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible. Distribution: Nationwide and Panama Quantity: 538,092/.5-fl. oz. bottles, 1,186,740/1-oz. bottles, and 138,528/1.25-fl. oz bottles Lot/code info: 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 record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.