Recalls / Class III

Class IIID-210-2013

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.

Affected lot / code info

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.

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

44,604/ .5-fl. oz. bottles and 439,452 /1-fl. oz. 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-210-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.