The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-207-2013·Announced 2013-03-27

Novartis Recalls Myoflex Cream Due to Illegible Lot and Expiration Dates

Novartis Consumer Health is recalling Myoflex Pain Relieving Cream because lot numbers and expiration dates may be illegible. The recall covers 2-oz and 4-oz tubes distributed nationwide and in Panama.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is limited to packaging legibility issues.

Plain-English summary

Novartis Consumer Health is voluntarily recalling specific lots of Myoflex (trolamine salicylate) 10% Pain Relieving Cream. The recall involves 2-oz and 4-oz over-the-counter tubes. The issue is that the lot number and/or expiration date on the packaging may be illegible, making it difficult to verify the product's identity and shelf life.

The affected products were distributed nationwide in the United States and in Panama. The recall includes 240,120 two-ounce tubes and 429,144 four-ounce tubes. Specific lot numbers and expiration dates ranging from March 2013 to October 2014 are listed in the official recall notice.

Consumers who have purchased these products should check their tubes against the list of affected lot numbers. If the lot number or expiration date is illegible or matches the recalled lots, consumers should stop using the product and contact Novartis Consumer Health for a refund or replacement. The FDA has classified this as a Class III recall, indicating that the labeling error is unlikely to cause adverse health consequences.

The recalled product

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.
Manufacturer
Novartis Consumer Health
Category
Drug — Topical Analgesic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Novartis Consumer Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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