Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide and Panama
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-210-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 7, 2013
- FDA report date
- Mar 27, 2013
- Quantity
- 44,604/ .5-fl. oz. bottles and 439,452 /1-fl. oz. bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Consumer Health
Original FDA data
Every field from FDA enforcement report D-210-2013, exactly as published.
Show all FDA fields
- City
- Lincoln
- State
- NE
- Status
- Terminated
- Country
- United States
- Event ID
- 64533
- Address
- 10401 Hwy 6
- 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.
- Postal code
- 68517-9626
- Report date
- Mar 27, 2013
- Product type
- Drugs
- Recall number
- D-210-2013
- Classification
- Class III
- Recalling firm
- Novartis Consumer Health
- Product quantity
- 44,604/ .5-fl. oz. bottles and 439,452 /1-fl. oz. bottles
- Termination date
- Nov 26, 2014
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Panama
- Recall initiation date
- Mar 7, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 21, 2013