Drug 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.
D-210-2013
Product summary
- Event
- Event 64533
- Status
- Terminated
- Classification
- Class III
- Quantity
- 44,604/ .5-fl. oz. bottles and 439,452 /1-fl. oz. bottles
- Official record key
drug-enforcement:D-210-2013
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Code information: 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, 10127556, 10127557, 10127558, and 10127559, Exp 3/13 to 10/13.
Distribution pattern: Nationwide and Panama
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing