Drug product
4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
D-211-2013
Product summary
- Event
- Event 64533
- Status
- Terminated
- Classification
- Class III
- Quantity
- 227,124 bottles
- Official record key
drug-enforcement:D-211-2013
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 #: 10107922, 10108365, 10108366, 10108367, 10109874, 10110021, 10110022, 10110023, 10110024, and 10120729, Exp 3/14 to 9/14.
Distribution pattern: Nationwide and Panama
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing