Class III · Low risk Terminated
DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-2829-1
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC…
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
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Class II · Moderate risk Terminated
DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-1211-95; OTC; OINTMENT
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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