Recalls / Class III

Class IIID-208-2013

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.

Affected lot / code info

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.

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.

Recalling firm

Firm

Novartis Consumer Health

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

10401 Hwy 6, N/A, Lincoln, Nebraska 68517-9626

Distribution

Quantity

91,872/1-oz. tubes and 94,464/2-oz. tubes

Distribution pattern

Nationwide and Panama

Timeline

Recall initiated

2013-03-07

FDA classified

2013-03-21

Posted by FDA

2013-03-27

Terminated

2014-11-26

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-208-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.