Drug Enforcement D-210-2013

Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.

Status

Terminated

Classification

Class III

Report Date

March 27, 2013

Termination Date

November 26, 2014

Product Information

Product description
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.
Product quantity
44,604/ .5-fl. oz. bottles and 439,452 /1-fl. oz. bottles
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Recall initiation reason
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Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
Nationwide and Panama

Location & Firm

Recalling firm
Novartis Consumer Health
Address
10401 Hwy 6, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-210-2013
Event ID
64533
Recall initiation date
March 7, 2013
Center classification date
March 21, 2013
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.
More code info
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