Recalls / Class III
Class IIID-211-2013
Product
4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
- Affected lot / code info
- Lot #: 10107922, 10108365, 10108366, 10108367, 10109874, 10110021, 10110022, 10110023, 10110024, and 10120729, Exp 3/14 to 9/14.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Recalling firm
- Firm
- Novartis Consumer Health
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 10401 Hwy 6, N/A, Lincoln, Nebraska 68517-9626
Distribution
- Quantity
- 227,124 bottles
- Distribution pattern
- Nationwide and Panama
Timeline
- Recall initiated
- 2013-03-07
- FDA classified
- 2013-03-21
- Posted by FDA
- 2013-03-27
- Terminated
- 2014-11-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-211-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.