Class III · Low risk
Dibucaine 1% Hemorrhoidal Ointment
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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
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.
Affected NDCs
0067-5812-86
0067-5812-96
Compare with the code on your package — it is the most precise check available.
Drug: Dibucaine
- 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 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Dibucaine recalls
See all
Class II · Moderate risk
Dibucaine Topical Anesthetic 1% Hemorrhoidal Ointment 28gm
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Novartis Consumer Health
All 2013 recalls
Class III · Low risk
Loratadine
Failed Tablet/Capsule Specifications: The products are being recalled due to chipped and broken tablets.
Class III · Low risk
Maalox Nighttime Antacid with Acid Reflux Barrier
Labeling: Incorrect or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Class III · Low risk
Maalox Nighttime Antacid with Acid Reflux Barrier
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Class III · Low risk
Maalox Extra Strength Antacid with Anti-Gas
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
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