CLASS III Drug recall · Reported 27 Mar 2013 · FDA Enforcement Report
Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic recalled
Novartis Consumer Health is recalling Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) tubes (, distributed nationwide in the US. The recall was initiated on 7 Mar 2013 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-208-2013
- FDA event ID
- 64533
- Recalling firm
- Novartis Consumer Health, Lincoln, NE
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Mar 2013
- FDA classified
- 21 Mar 2013
- Reported
- 27 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 7 Mar 2013 | Recall initiated by company | |
| 21 Mar 2013 | Classified by FDA | +14 days |
| 27 Mar 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Panama
Questions about this recall
Is Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) tubes ( recalled?
Yes. Novartis Consumer Health recalled Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) tubes ( on 7 Mar 2013. The recall is Class III and its status is Terminated. Recall number D-208-2013.
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Which lots are affected?
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 was it sold?
Nationwide and Panama
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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