FDA recall D-209-2013

Novartis Consumer Health · Class III · drug

Product

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.

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

Key facts

Status: Terminated
Initiation date: 2013-03-07
Report date: 2013-03-27
Termination date: 2014-11-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lincoln, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-209-2013