Drug 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.
D-208-2013
Product summary
- Event
- Event 64533
- Status
- Terminated
- Classification
- Class III
- Quantity
- 91,872/1-oz. tubes and 94,464/2-oz. tubes
- Official record key
drug-enforcement:D-208-2013
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Code information: 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 pattern: Nationwide and Panama
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing