Class III · Low risk Terminated
Dibucaine 1% Hemorrhoidal Ointment
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Nupercainal
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
What was recalled
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.
- Recalling firm
- Novartis Consumer Health
- NDC code
- 0067-5812-96
- Origin
- NE, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-208-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Dibucaine recalls
See all
Class II · Moderate risk Terminated
Dibucaine Topical Anesthetic 1% Hemorrhoidal Ointment 28gm
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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