Recalls / Class III

Class IIID-207-2013

Product

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.

Affected lot / 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.

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

240,120/2-oz. tubes and 429,144/4-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-207-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.