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
Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
Lot numbers, UPCs & expiration codes
Lot #: a) 10109149, 10111499, 10117160, 10119603, and 10121763, Exp 4/13 to 8/13; b) 10109148, 10112258, 10113806, 10115615, 10117161, 10119604, 10119605, 10121782, and 10122762, Exp 3/13 to 9/13.
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-208-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 7, 2013
- FDA report date
- Mar 27, 2013
- Quantity
- 91,872/1-oz. tubes and 94,464/2-oz. tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Consumer Health
Original FDA data
Every field from FDA enforcement report D-208-2013, 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) 10109149, 10111499, 10117160, 10119603, and 10121763, Exp 4/13 to 8/13; b) 10109148, 10112258, 10113806, 10115615, 10117161, 10119604, 10119605, 10121782, and 10122762, Exp 3/13 to 9/13.
- Postal code
- 68517-9626
- Report date
- Mar 27, 2013
- Product type
- Drugs
- Recall number
- D-208-2013
- Classification
- Class III
- Recalling firm
- Novartis Consumer Health
- Product quantity
- 91,872/1-oz. tubes and 94,464/2-oz. tubes
- 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
- Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), 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