Drug 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.
D-207-2013
Product summary
- Event
- Event 64533
- Status
- Terminated
- Classification
- Class III
- Quantity
- 240,120/2-oz. tubes and 429,144/4-oz. tubes
- Official record key
drug-enforcement:D-207-2013
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) 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.
Distribution pattern: Nationwide and Panama
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing