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Recall Observatory FDA recall evidence

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

March 07, 2013

Class III

Product summary

Firm
Novartis Consumer Health
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

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing