Drug Enforcement D-207-2013

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

Status

Terminated

Classification

Class III

Report Date

March 27, 2013

Termination Date

November 26, 2014

Product Information

Product description
Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label is Novartis Consumer Health, Inc., Parsippany, NJ 07054.
Product quantity
240,120/2-oz. tubes and 429,144/4-oz. tubes
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Recall initiation reason
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
Nationwide and Panama

Location & Firm

Recalling firm
Novartis Consumer Health
Address
10401 Hwy 6, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-207-2013
Event ID
64533
Recall initiation date
March 7, 2013
Center classification date
March 21, 2013
Code info
Lot #: a) 10086783, 10088745, 10088746, 10090537, 10093867, 10093868, 10098162, 10098541, 10098542, 10102311, 10109145, 10109146, 10120111, 10122759, and 10122760, Exp 3/13 to 9/14; b) 10086785, 10088747, 10088748, 10090538, 10093869, 10093870, 10098160, 10098161, 10098540, 10099841, 10104146, 10109143, 10109144, 10111501, 10115614, 10120112, 10121759, 10122698, 10122757, and 10122758, Exp 3/13 to 10/14.
More code info