Novartis Recalls Nupercainal Ointment Due to Illegible Labeling
Novartis Consumer Health is recalling Nupercainal Ointment because lot numbers and expiration dates may be illegible or missing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, and the issue is limited to packaging and labeling defects.
Plain-English summary
Novartis Consumer Health is recalling Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment in 1-oz. and 2-oz. tubes. The recall is due to labeling issues where the lot number and/or expiration date may be illegible or missing.
The affected products are distributed nationwide and in Panama. The recall includes specific lot numbers with expiration dates ranging from March 2013 to September 2013.
Consumers should check their products for the affected lot numbers and expiration dates. If the labels are illegible or missing, consumers should stop using the product and contact Novartis Consumer Health for instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Novartis Consumer Health
- Category
- Drug — Topical Analgesic
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- 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.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Novartis Consumer Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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